Including - Smith & Nephew
Contents
1. TRIGEN META NAIL Tibial Nail System Including TRIGEN SURESHOT Distal Targeting System TRIGEN META NAIL Tibial Nail System Surgical Technique Table of contents Indications 2 222 2 2 4 4 44 2 Implant specifications 4 Surgical technique 5 Incision and entry 12 Entry portal acquisition 13 Entry portlal 14 Alternative technique Entry portal 14 Fracture reduction LLL LL RL EROR 16 Reducer removal a a 16 Implant 17 Unreamed technique 18 Reamed 19 Nallassembly 21 Pal Gil RET 27 Check nail 28 Locking screw measurement 35 Locking screw insertion 35 Proximal locking Static 36 Proximal locking 36 Proximal locking Compression 372. Pass screen Menu Fion roos Gite MEA When targeting correctly a pass screen will occur About The About screen provides more information about the software used Shutdown muraio Tamni Tap on screen to shut down the system before flipping the power switch 40 Error message Menu gt An error message will occur if a probe sensor is SURESHOT Targeter invalid or broken 7 Distal blocking screws with Menu Tibia 1mm Short Sleeve TRIGEN SURESHOT The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5mm from the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm from the sides of 8 5mm IN nails 41 Troubleshooting Problem Possible cause Suggested action Trauma Interface unit is without power Mains power plug is not inserted properly or there is no mains power Insert mains power plug into reliable power supply No power on the wall outlet Try other power outlet One or both mains power fuses are blown Replace mains fuses Buttons or items are difficult to select on the touchscreen Touchscreen is de calibrated Access calibration software by selecting Maintenance from the About option under the Menu options password required VGA video out not functioning VGA port not activated on Trauma Interfa
3. Blocking screw technique Incision and entry 45 Entry portal acquisition 45 AP blocking screw insertion 46 ML blocking screw insertion 47 Blocking screw insertion with reducer 48 Stability blocking screw insertion 49 cap 50 Nail extraction Optional Standard technique 52 Percutaneous technique 52 Guide rod jamming 1 59 Catalog information 54 Nota Bene The technique description herein is made available to the healthcare professional to illustrate the authors suggested treatment for the uncomplicated procedure In the final analysis the preferred treatment is that which addresses the needs of the patient Indications The TRIGEN META NAIL Tibial Nail is indicated for fractures of the proximal and distal third of the tibia including the shaft stable and unstable fractures nonunions malunions and for the prophylactic nailing of impending pathological fractures TRIGEN SURESHOT indications Legend Important warnings appear in oran
4. 92 An alternative method for extraction Guide rod jamming technique Advance the end of a 3 0mm Ball Tip Guide Rod through the end of the nail Insert a 2 0mm Smooth Guide Rod 7111 8280 in the same manner With both guide rods in place attach the Gripper to the end of the 3 0mm Ball Tip Guide Rod and pull it back so that it wedges the ball tip against the 2 0mm Smooth Guide Rod Backslap against the Gripper with the Slotted Hammer to extract the nail Guide rods Cat No Description 7111 8280 2 0mm x 900mm Smooth RUSSELL TAYLOR System 7111 8202 3 0mm x 900mm Ball Tip RUSSELL TAYLOR System 7163 1626 3 0mm x 1000mm Ball Tip TRIGEN System Additional removal items Cat No Description 115074 Large Extractor Hook 115073 Small Extractor Hook 914658 Large Easy Out 914659 Small Easy Available sterile packed For nail removal only do not use for nail insertion Located in RUSSELL TAYLOR Extraction Kit Set 7508 available through Loaners 59 Catalog information META NAIL Implants TRIGEN Internal Captured Screws 4 5mm and 5 0mm Set No 7163 1321 Cat No 7164 2125 7164 2130 7164 2135 7164 2140 7164 2145 7164 2150 TRIGEN META NAIL 8 5mm Tibial Length 4 5mm x 25mm 4 5mm x 30mm 4 5mm x 35mm 4 5mm x 40mm 4 5mm x 45mm 4 5mm x 50mm Set No 165 3002 Cat No 165 5024 165 5026 165 5028 7165 5029 7165 5030 165 5031 165 5032 165
5. Nail Cap Set Screw Cat No 7165 6000 Medium Hexdriver Cat No 7163 1066 Mini Connector Cat No 163 1186 4 0mm Drill Sleeve Cat No 7167 4083 II 9 0mm Drill Sleeve Cat No 7163 1152 Screwdriver Release Cat No 7167 4084 4 0mm Long Pilot Drill Cat No 7163 1110 Universal META NAIL Compression Driver Cat No 7165 4528 4 0mm Short Drill Cat No 7163 1117 T handle Cat No 7167 4076 Screw Depth Gauge Cat No 7163 1189 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 A Omm Short Drill 7163 1117 is interchangeable with 4 0mm AO Short Drill 7163 1123 34 Locking screw measurement There are three methods 1 Gold 9 0mm Drill Sleeve silver 4 0mm Drill Sleeve and 4 0mm Long Pilot Drill 2 Screw Depth Gauge 7163 1189 3 Screw Length Sleeve 7167 4085 and 4 0mm Short Drill 163 1117 Locking screw insertion Proximal locking options include three statically locked threaded holes and one slot that allows for both fracture compression and or dynamization These are targeted through the orange and blue color coded holes on the Anterior Drop Distal locking options include three statically locked holes two ML and one AP The most distal ML hole is threaded for additional stability Gold 5 0mm locking screws are compatible with 10mm 11 5mm and 13mm diameter nails and grey 4 5mm locking screws wi
6. SURESHOT Instruments TRIGEN SURESHOT Country Kit North America Cat No 7165 7003 Cat No Description Qty 6680 0193 Power Cord 125 Volt 10 Amp North 1 America Hospital Grade 7118 1540 User Manual English 1 Additional country kits TRIGEN SURESHOT Country Kit Australia Cat No 7165 7004 Cat No Description Qty 6680 0303 Power Cord 250 Volt 10 Amp 1 Australia NZ 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit Continental Europe Cat No 7165 7005 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit Germany Cat No 7165 7006 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1538 User Manual German 1 TRIGEN SURESHOT Country Kit Spain Cat No 7165 7007 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 1 Continental Europe 7118 1539 User Manual Spanish 1 64 TRIGEN SURESHOT Country Kit France Cat No 7165 7008 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1537 User Manual French 1 TRIGEN SURESHOT Country Kit Italy Cat No 7165 7009 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 Amp 1 Continental Europe 7118 1536 User Manual Italian 1 TRIGEN SURESHOT Country Kit United Kingdom Cat No 7165 7011 Cat
7. With the nail inserted attach the Tibial Blocking Screw Attachment 7165 4509 to the Anterior Drop Triangle to Triangle for AP screws and Square to Square for ML screws Follow the previously described technique for Cartridge positioning and blocking screw insertion Note The AP blocking screws targeted through the two 2 holes built into the Anterior Drop cannot be used if the most inferior oblique proximal locking screw has been inserted Distal blocking screws with Menu SURESHOT The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5mm from the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm from the sides of 8 5mm IM nails 49 Final view Stability blocking screws Once stability blocking screw insertion is complete remove the Blocking Screw Attachment and Anterior Drop from the drill guide and obtain both AP and lateral radiographic images to confirm accurate placement TRIGEN nail cap insertion optional Remove the drill guide Anterior Drop assembly Attach the selected Nail Cap to the Medium Hexdriver T handle assembly insert into the top of the nail until tight A Nail Cap cannot be used if a Nail Cap Set Screw is implanted or if a locking screw is inserted in the dynamic locking position The tip of the Nail Cap will contact the locking screw and prevent
8. Drilling mode manual rotation eu Tibia 10 Short Each IM nail has several predefined views that are automatically selected depending on the position of the Targeter to the IM nail Depending on the operating environment these predefined views might not be appropriate and can be manually adjusted To rotate the view Touch the screen near the outside and drag the view in a clockwise or counterclockwise direction To flip the view Tic rm Short sleeve Touch the Menu button and select Toggle Back View All changes made for a view are temporarily stored for that view until program exit To reset the view The default view settings can be restored by touching the Menu button and selecting Reset View or double tapping the center of the screen 38 Menu Options Menu Tapping on the Menu button will open up several Menu oplions Toggle back view Mu Tic lOmin Short Sieve This view may be used in cases where the Trauma Interface cannot be placed in front of the surgeon It is intended to be used similar to the mirror option commonly available on C Arm machines Implant When choosing an implant several options are given Tap on screen to select Drill sleeve Men Tap on screen to select appropriate drill sleeve 39 Field check Fail screen meaning that something is not targeting correctly See Troubleshooting section for further information
9. No 7167 4076 Entry Portal Tube Cat No 7167 4060 3 2mm T handle Trocar Entry Portal Handle Cannulated Awl Cat No 7167 4092 Cat No 7167 4000 Incision and entry point Assemble the Honeycomb 7167 4075 Entry Portal Handle 7167 4092 and Entry Portal XM n Tube 7167 4060 The pieces will lock in place securely at either 0 or 180 A 2cm incision is made in line with the intramedullary canal This may be patellar splitting medial or lateral parapatellar in its orientation The entry point is located just medial to the lateral tibial eminence in the AP view and in line with the anterior cortex and intramedullary canal in the lateral view Entry portal acquisition Attach a 3 2mm Tip Threaded Guide Wire 7163 1690 to the drill via the Mini Connector 163 1186 and insert into the proximal tibia to a depth of 4 6cm The Entry Portal instrumentation serves as a soft tissue protector In the instance of suboptimal Guide Wire insertion rotate the Honeycomb within the Entry Tube to the desired location and insert another 3 2mm Tip Threaded Guide Wire Avoid over insertion of the Guide Wire as this can establish a false trajectory and lead to fracture malalignment Entry portal After definitive Guide Wire placement remove the Honeycomb from the Entry Tube along with any additionally inserted Guide Wires and attach the 12 5mm Entry Reamer 7163 1116 to power Advance over t
10. complete engagement of the Nail Cap with the nail Note If cross threading occurs rotate the Nail Cap counterclockwise until its threads line up with those of the nail Proceed with insertion until tight 50 Instruments for implant removal 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 creber S 12 5mm Entry Reamer Cat No 7163 1116 Mini Connector Cat No 7163 1186 Disposable Nail 1 Cat No 7163 1320 Cannulated Impactor Medium Cannulated Impactor Long Cat No 7167 5081 Cat No 7163 1185 t T handle Cat No 7167 4076 eoa Medium Hexdriver Cat No 7163 1066 Additional guide rods listed on page 53 3 0mm 1000mm Ball Tip Guide Rod Cat No 7163 1626 Slotted Hammer Cat No 7167 4082 The Cannulated Impactor Long is located in the original TRIGEN Instrument Set 7163 1326 The Disposable Nail Extractor 7163 1320 is interchangeable with the Large Nail Extractor 7163 1278 located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 51 Nail extraction optional Standard technique Remove the Nail Cap or Nail Cap Set Screw if implanted and all of the distal locking screws with the Medium Hexdriver T handle assembly Remove all of the proximal locking screws except for one in the same manner Thread the Cannulated Impactor Medium 167 5081 or Cannulated Impactor Long 7163
11. have existing TRIGEN set Set No 7163 1326 Medium Hexdriver Cat No 7163 1066 Short Hexdriver Cat No 7163 1068 Gripper Cat No 7163 1100 Entry Tool Cat No 7163 1114 12 5mm Entry Reamer Cat No 7163 1116 Obturator Cat No 7163 1122 Reducer Cat No 7163 1124 Ruler Cat No 7163 1128 Guide Bolt Wrench Cat No 7163 1140 Hammer Cat No 7163 1150 9 0mm Drill Sleeve Cat No 7163 1152 4 0mm Drill Sleeve Cat No 7163 1156 Multipurpose Driver Cat No 7163 1161 T handle Cat No 7163 1172 6 Catalog Information META NAIL Instruments Mini Connector Cat No 7163 1186 Screw Depth Gauge Cat 7163 1189 Screw Driver Release Handle Cat No 7163 1208 Cannulated Impactor Long b Cat No 7163 1185 Flexible Reamer Shaft Cat No 7163 1192 Reamer Heads Cat No 7111 8231 8242 META NAIL Disposables Set No 7165 4003 4 0mm Long Pilot Drill Cat No 7163 1110 Cat No 7163 1117 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 Universal Compression Driver ER Cat No 7165 4528 Disposable Nail Extractor Cat No 7163 1320 4 0mm Long Pilot Drill 163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 4 0mm Short Drill 7163 1117 is interchangeable with 4 0mm AO Short Drill 7163 1123 The Disposable Nail E
12. 1185 into the back of the Disposable Nail Extractor 7163 1320 and then thread the assembly into the top of the nail Remove the remaining proximal locking screw and then extract the nail with a back slapping motion using the Slotted Hammer Percutaneous technique This technique assumes the absence of a Nail Cap or Nail Cap Set Screw Remove all distal locking screws and all but one of the proximal locking screws as previously described Under fluoroscopy insert a 3 2mm Tip Threaded Guide Wire 7163 1690 into the top of the nail on power or by hand Make a 2cm incision around the pin and advance the 12 5mm Entry Reamer over the pin and into the top of the nail to remove any bony ingrowth Thread the Cannulated Impactor Medium or Cannulated Impactor Long 7163 1185 into the back of the Disposable Nail Extractor 163 1320 and then thread the assembly into the top of the nail Remove the remaining proximal locking screw and then extract the nail with a back slapping motion Note The tip of the Entry Reamer is straight for approximately 1cm before flaring out It is this portion of the Entry Reamer that enters the top of the nail Cannulated Impactor Long is located in the original TRIGEN Instrument Set 7163 1326 Disposable Nail Extractor 7163 1320 is interchangeable with the Large Nail Extractor located in the original TRIGEN Instrument Set 7163 1326 and the Instrument Set 7170 0001
13. 5033 165 5034 Contained in the standard implant set 54 Length 24cm 26cm 28cm 29cm 30cm 31cm 32cm 33cm 34cm Cat No 7164 2225 7164 2230 7164 2235 7164 2240 7164 2245 7164 2250 7164 2255 7164 2260 7164 2265 7164 2270 7164 2275 Cat No 7165 5035 7165 5036 7165 5037 7165 5038 7165 5039 7165 5040 7165 5041 7165 5042 Length 5 0mm x 25mm 5 0mm x 30mm 5 0mm x 35mm 5 0mm x 40mm 5 0mm x 45mm 5 0mm x 50mm 5 0mm x 55mm 5 0mm x 60mm 5 0mm x 65mm 5 0mm x 70mm 5 0mm x 75mm Length 35cm 36cm 37cm 38cm 39cm 40cm 41cm 42cm 4 5mm 5 0mm TRIGEN META NAIL 10mm Tibial Set No 7165 3000 Cat No Length Cat No Length 7165 5124 24cm 7165 5135 35cm 7165 5126 26cm 7165 5136 36cm 165 5128 28cm 7165 5137 3 cm 7165 5129 29cm 7165 5138 38cm 7165 5130 30cm 7165 5139 39cm 7165 5131 31cm 7165 5140 40cm 7165 5132 32cm 7165 5141 41cm 7165 5133 33cm 7165 5142 42cm 7165 5134 34cm TRIGEN META NAIL 11 5mm Tibial Set No 7165 3001 Cat No Length Cat No Length 7165 5224 24cm 7165 5235 35 7165 5226 26cm 7165 5236 36cm 7165 5228 28cm 7165 5237 37cm 7165 5229 29cm 7165 5238 38cm 7165 5230 30cm 7165 5239 39cm 7165 5231 3lcm 7165 5240 40cm 7165 5232 32cm 7165 5241 41cm 7165 5233 33cm 7165 5242 42cm 165 5234 34cm Contained in the standard implant set Catalog information META NAIL Implants TRIGEN META NAIL 13mm Tibi
14. Drop down to bone Drill both cortices with the 4 0mm Long Pilot Drill Screw measurement and insertion follows the previously described technique Note If nail is left in dynamic mode a nail cap cannot be used as it will push against the locking screw 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 163 1121 36 N Oi Proximal locking Compression There are two 2 methods Compression Driver method Countersink the nail a minimum of 10mm and lock the nail distally Reduce the fracture as much as possible to maximize the advantage of the compression driver Insert a screw through the proximal side of dynamic slot as previously described Remove the gold 9 0mm Drill Sleeve and Medium Hexdriver Attach the Universal Compression Driver 7165 4528 to the T handle and thread it through the guide bolt into the top of the nail until it contacts the most proximal 5 0mm locking screw Advance the Compression Driver clockwise to drive the locking screw distally which will compress the fracture up to 7mm Once the fracture gap is adequately compressed lock the nail with up to three additional proximal static screws while the Anterior Drop is still attached to the drill guide Nail Cap Set Screw method Lock the nail distally fully insert the dynamic locking screw as previously described and remove the Drill Guide Anterior Drop assembly Insert
15. No Description Qty 6680 0213 Power Cord 250 Volt 10 Amp UK 1 7118 1540 User Manual English 1 TRIGEN SURESHOT Country Kit South Africa India Cat No 7165 7012 Cat No Description Qty 6680 0302 Power Cord 250 Volt 10 Amp 1 So Africa India 7118 1540 User Manual English 1 65 Orthopaedics Smith amp Nephew Inc www smith nephew com 1450 Brooks Road Memphis TN 38116 USA Telephone 1 901 396 2121 Information 1 800 821 5700 Orders Inquiries 1 800 238 7538 2012 Smith amp Nephew Inc All rights reserved Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM 7118 1610 REVA 04 12
16. Note For assembly screw on set stop to drill guide then insert probe Note The probe will be used as an intramedullary tool inside the nail placed in the patient s bone Note If the probe is not recognized after connection to the system the probe is W L defective and must be exchanged 3 See also instrument connection Note Broken or damaged instruments must immediately sent i Smith amp Nephew Inc Note This device is provided sterile by ethylene m oxide gas and is single use Red probe Blue probe Use only with Use only with META NAIL META NAIL Standard Drill Guide Semi extended Drill Guide There will be a confirmation on the screen of the Trauma Interface that implies that the probe has been connected SURESHOT Probe META Standard Tip When oriented as shown the connector should assemble easily Do not force the connector into the port Note If the probe is properly connected to the system and the application reports Probe not found for more than 10 seconds the probe may be damaged or defective In this case the probe has to be exchanged Tip It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument 22 Green probe Use only with Percutaneous TANP FAN Drill Guide 7163 1021 SURESHOT Targeter conne
17. al Cat No Length Cat No Length 7165 5318 18cm 7165 5335 35cm 7165 5320 20cm 7165 5336 36cm 7165 5322 22cm 7165 5337 37cm 7165 5324 24cm 7165 5338 38cm 7165 5326 26cm 7165 5339 39cm 7165 5328 28cm 7165 5340 40cm 7165 5329 29cm 7165 5341 41cm 7165 5330 30cm 7165 5342 42cm 7165 5331 31cm 7165 5343 43cm 7165 5332 32cm 7165 5344 44cm 7165 5333 33cm 7165 5346 46cm 7165 5334 34cm 7165 5348 48cm 7165 5350 50cm Nail Cap Set Screw Cat 7165 6000 Nail Caps Cat No Length Cat No Length 7163 4000 Omm 7163 4015 15mm 7163 4005 5mm 7163 4020 20mm 7163 4010 10mm 56 Catalog information META NAIL Implants TRIGEN META NAIL Blocking Screw Instruments Set No 7165 4001 Blocking Screw Device Cat No 7165 4515 Tibial Blocking Screw Attachment Cat No 7165 4509 11 0mm T handle Awl Cat No 7165 4522 8 5mm 10mm Blocking Screw Cartridge Cat No 7165 4511 11 5mm 13mm Blocking Screw Cartridge Cat No 7165 4513 Offset Blocking Screw Cartridge Cat No 7165 4514 Blocking Screw Alignment Pin Cat No 7165 4523 Blocking Screw Instrument Case Cat No 7165 4552 Blocking Screw Instrument Lid Cat No 7165 4553 57 Catalog information META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set 7165 4002 META NAIL Anterior Drop Cat No 7165 4501 META NAIL Drill Guide Cat No 7165 4502 META NAIL Extension Drill G
18. ameter Screw Color Major Diameter Minor Diameter core Screw Lengths Hex Size Alternative Hexdrivers Alternative Modes Static Lock Locations Orientations Static Locking Hole Dimensions Compression Dynamic TI6AL4V 8 5mm 16 50cm Grey Round 12mm 8 5mm 4 8mm 1 9mm 5 16 24 UNF 4 5mm Grey 4 5mm 4 0mm 25 65mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC Locking Screw No TI6AL4V 10 11 5 amp 13mm 16 50cm Gold Round 12mm 10 11 5 dia 13mm 13 dia 10 11 5 amp 13mm 5 0mm 2 3mm 10 3 0mm 11 5 2 3mm 13 5 16 24 UNF 5 0mm Gold 5 0mm 4 3mm 25 110mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC 4 7mm Hexdriver PROFIX 4 7mm Hexdriver No 17mm 45 Screw Locked w META NAIL Cap 23mm 45 Threaded w bushing 30mm 25 Threaded 40mm 25 Threaded Threaded 4 3mm minor dia Threaded 4 7mm major dia Threaded 4 5mm minor dia Threaded 5 3mm major dia 10mm 10mm Slot Location Compression Dynamic 4 7mm 7mm 5 3mm 7mm 2 Slot Diameter Length Degree of Proximal Bend M view Non driving end of nail AP view 10 10 Herzog Proximal Bend Location 27mm 27mm Note These views are not to scale and should EXE mm ML 25mm ML i i i Static Lock Locations be used as a pictorial representation only M Orientations 5mm ML Threaded 5mm ML Threaded Static Locking Hole 4 7mm Di
19. by connecting it to the T handle 167 4076 Note If blocking screws are desired at this point in the procedure refer to the blocking screw technique section pp 45 50 Advance the Reducer into the intramedullary canal and use the curved tip to direct the 3 0mm Ball Tip Guide Rod past the fracture into the region of the distal epiphyseal scar The guide rod should be center center in the AP and lateral views Reducer removal Once the guide rod is at the desired depth detach the Gripper and remove the Reducer 9o from the tibial canal Slide the Obturator 167 4078 into the back of the T handle during extraction in order to maintain guide rod position within the canal Implant measurement After Reducer removal reconfirm guide rod placement within the distal tibia and slide the Ruler 7167 4079 over the guide rod to the desired depth The metal tip of the Ruler denotes the driving end of the META NAIL Tibial Nail Confirm guide rod position in the window at the opposite end of the Ruler as shown in order to ensure accurate implant measurement Push down on the top of Ruler until contact is made with the 3 0mm Ball Tip Guide Rod Implant length is read from the exposed calibrations at the end of the Ruler Note Confirm fracture reduction so as not to underestimate correct implant length Reference the fibula for accurate fracture distraction or compression Note Confirm that the Ruler opens easily Adjust t
20. ce Connect VGA cable to both Trauma Interface and video monitor before powering on Trauma Interface Damaged VGA cable Replace VGA cable Video monitor not on correct input Select proper input on video monitor TRIGEN SURESHOT Targeter not recognized Error reading data from Targeter Unplug Targeter wait 10 seconds plug back in Damaged Targeter Replace Targeter with new unit Probe not recognized Error reading data from probe Unplug probe wait 10 seconds plug back in Damaged probe Replace probe with new unit Probe will not insert to the proper depth in the nail Obstruction within the nail cannulation Re insert the ball tip guide rod into the nail cannulation to clear any obstruction Nail not visible on the screen Metal interference Remove any metal objects from within the TRIGEN SURESHOT the targeting field electromagnetic field TRIGEN SURESHOT Targeter Move the TRIGEN SURESHOT and probe not within range of Targeter closer to the sensor each other end of the probe Drill bit too short Short drill bit being used and long drill sleeve option selected within software Press Menu Drill Sleeve and select the short drill sleeve option and use the short drill bit Drill bit too long Long drill bit being used and short drill sleeve option selected within software Press Menu Drill Sleeve and select the long drill sleeve opti
21. ce the nail has been fully seated and attach the Anterior Drop Note Following nail insertion confirm that the nail and drill guide are securely connected as hammering can loosen the Guide Bolt 28 Devices to lock distally rp gt smith amp nephew SURESHOT Distal Targeting System TRIGEN SURESHOT Targeter Cat No 169 2801 Trauma Interface Cat No 7169 2802 Power Cord AO Drill Bit Short Cat No 6680 0193 Cat No 7169 2810 AO Drill Bit Long Ee Cat No 7169 2811 Drill Sleeve Long Cat No 7169 2804 Hexdriver Drill Sleeve Short Cat No 7169 2805 La META NAIL Standard Drill Guide Probe META Set Stop Cat No 7169 2814 Cat No 7169 2806 Note When the Targeter is out of the preferred range or there is metal or electrical interference the green and red Targeter circles on the Trauma Interface screen may become unstable and or a warning message will be displayed If the interference is excessive the IM nail image on the Trauma Interface screen will disappear If interference cannot be avoided a standard X Ray technique must be used Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume 29 Detach Cannulated Impactor Medium 7167 5081 from drill guide Reattach META Set Stop 7169 2806 and insert META NAIL Standard Drill Guide Probe 7169 2814 in the
22. cepts no responsibility or liability whatsoever for the functioning or utility of the TRIGEN SURESHOT Distal Targeting System when used in the operating theatre Cleaning and sterilization All instruments must be sterilized before use Detailed information on the cleaning and sterilization of components is contained in the separate Cleaning and Sterilization Instructions Smith amp Nephew document 7138 1339 Repair or modifications to the system The user is not permitted to modify or service the equipment There are no serviceable parts inside the unit Refer all service to authorized personnel Modifications additions to the software The user is not permitted to install or uninstall software Any new software must be installed by the manufacturer or by authorized personnel It is only allowed to connect equipment to the interface and power supply connections of the TRIGEN SURESHOT Distal Targeting System which IEC60601 1 approved and which are approved by Smith amp Nephew Orthopaedics Do not modify this equipment without authorization of the manufacturer Electrical safety warning To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth ground Avoid spilling water or other liquids on electronic electrical equipment Use only Smith amp Nephew disposables and accessories with the Smith amp Nephew TRIGEN SURESHOT Distal Targeting System Maintenance To verify acc
23. cted After TRIGEN SURESHOT Targeter and probe Menu have been connected attach drill sleeve to Targeter The displayed screen will occur Select the length of the drill sleeve 7169 2804 Snor meme meng aeee or 7169 2805 that will be used Generally the short sleeve is sufficient In some cases using the femoral retrograde technique the long sleeve needs to be used Tip A different sleeve can be selected at any time during the procedure by choosing the drill sleeve option from the drop down menu after the implant has been selected The selected sleeve will be noted on the Trauma Interface screen Drill sleeve attachment Tightly secure the selected drill sleeve to Tip The drill sleeve 7169 2804 and 7169 2805 the Targeter can be loosened from the Targeter using the slot in the TRIGEN Slotted Hammer 7167 4082 Select the TRIGEN IM nail and size that will Menu be used Tip A different TRIGEN IM nail and or size can Tibia be selected at any time during the procedure by choosing the Implant option from the drop down menu The selected implant and diameter will be noted on the Trauma Interface screen 9 23 Locking hole accuracy check in the operative field Insert the probe with the assembled set stop through the drill guide and cannulation of the IM nail Tip The guide bolt wrench 7163 1140 may be Note The TRIGEN SURESHOT Distal used as a lever to release the set st
24. curacy check steps Attach TRIGEN SURESHOT Field Accuracy Gauge 169 2808 to TRIGEN SURESHOT Targeter The knob on the Field Accuracy Gauge should be hand tightened only Attach the TRIGEN SURESHOT META Set Stop 169 2806 to the end of the Field Accuracy Gauge insert a TRIGEN SURESHOT probe into the set stop and set the depth to the REF mark on the probe body From the software Menu button select Field ven Check option 25 4 A software window will appear informing the Menu Held Check Gauge user if the TRIGEN SURESHOT Targeter and Probe combination is within the predefined accuracy parameters or Fail message 5 If the field accuracy check fails check the Held Check Gouge MEZ Troubleshooting section of this document for possible solutions Note This step should be performed at least once a year to ensure that the device is working properly 26 Nail insertion Detach Anterior Drop and set stop and attach impactor Remove the Anterior Drop and attach the Cannulated Impactor Medium 7167 5081 to the drill guide Orient the drill guide assembly in the AP position and advance the nail over the guide rod by light blows from the Slotted Hammer 167 4082 to the desired depth Additional reaming of the intramedullary canal may be indicated if excessive force is required to insert the nail Verify fracture reduction as the nail crosses the fractur
25. d through Targeter TRIGEN SURESHOT Targeter is backed away from bone by sleeve length approximately 80mm for the short sleeve Note Image disappears if too close Note The standard TRIGEN Hexdrivers are made from magnetic stainless steel that will cause interference with the system and cannot be used Insert the bone screw into the pre drilled hole through the nail and through the far cortex Note For 10 11 5 13mm nails use TRIGEN Internal Captured Screws 5 0mm gold for 8 5mm nails use TRIGEN Internal Captured Screws 4 5mm grey Before fully inserting the screw remove power drill and Targeter Final screw seating must be done by hand by attaching the T handle 7167 4076 to the Medium Hexdriver 7163 1066 The depth of the screw can be verified by placing a gold 9 0mm Drill Sleeve 7163 1152 down to bone over the hexdriver There is a profile of the screw head and a groove on the hexdriver that may be used as an indicator for the position of the screw head relative to the near cortex Positioning of the screw can be verified with the C Arm Repeat with other distal screws Note Remove probe before proceeding to proximal locking Remove the probe from the set stop Detach set stop from the drill guide Do not pull the cable to remove probe 33 Instruments for standard dynamic and compression locking Screw Length Sleeve 1 Cat No 7167 4085 META NAIL Anterior Drop Cat No 7165 4501
26. d in the ML plane Attach the Blocking Screw Device to the 11 0mm T handle Awl and rotate it into the desired position in the ML plane Tighten the device to the awl and insert the appropriate Blocking Screw Cartridge Adjust the cartridge proximally or distally within the Blocking Screw Device to determine blocking screw position Blocking screw insertion follows the previously described technique 47 Blocking screw Insertion with reducer Blocking screw insertion can also be performed by attaching the Blocking Screw Device to the Reducer instead of the 11 0mm T handle Awl Blocking screw insertion follows the previously described technique Final view AP and ML blocking screw insertion Once blocking screw insertion is complete remove the Blocking Screw Device from the 11 0mm T handle Awl or Reducer and obtain both AP and lateral radiographic images to confirm accurate placement The awl or Reducer provides a good indication of the nail s insertion trajectory based upon the location of the blocking screws Following confirmation of proper screw placement proceed with nail insertion following the META NAIL Tibial Nail insertion technique 48 Stability blocking screw insertion Following nail insertion and confirmation of fracture reduction blocking screws can be placed on either side of the nail in the metaphyseal region for additional stability Screws may be inserted in both the AP and ML planes
27. e between two circles of the red circle until both circles are concentric and centered with the desired hole on the screen Then start drilling Note The green ring must be fully within the hole of the IM nail displayed on the Trauma Interface screen to ensure accurate drilling 3 Drilling distal hole Drill through near cortex and the nail using the TRIGEN SURESHOT 4 0mm Drill Bit 7169 2810 or 169 2811 Before drilling through far cortex obtain the screw measurement Note Important if standard 4 0mm drill from TRIGEN set is used magnetic metal can adversely affect accuracy causing the drill to miss Verify there is no other magnetic metal object in area other than the items shown A note will appear on screen warning of compromised targeting field if magnetic metal is close If it is in the field image disappears Screw measurement With the tip of the drill against the far cortex measure for length then drill through the far cortex Ensure the serrated tip of the drill sleeve is pushed against the bone Example Measure 35mm add approximately 5mm the screw length would be 40mm Alternative screw measurement with depth gauge 7163 1189 After successtully drilling through the screw hole of the nail with the TRIGEN SURESHOT 4 0mm Drill Bit remove the drill bit being careful not to move the leg 32 Screw insertion Detach Drill Sleeve from Targeter Introduce Hexdriver with the screw attache
28. e site paying close attention to rotation length alignment distraction and or shortening Check final nail position in both the AP and lateral views for correct alignment Tip Provisional fixation of the proximal tibial fragments may be obtained by reattaching the Anterior Drop and by inserting the gold 9 0mm Drill Sleeve 7163 1152 and silver 4 0mm Drill Sleeve 7167 4083 into one of the two Blocking Screw holes in the Drop and passing a 4 0mm Long Pilot Drill 7163 1110 For proximal interlocking with the leg in extension use the Extension Drill Guide 165 4503 and Extension Guide Bolt 165 4505 The long insertion barrel of the standard drill guide may impinge upon the distal femoral condyles and prevent nail interlocking with the tibia in full extension Note TRIGEN SURESHOT cannot be used with this guide 2 Check nail depth Proximal In the lateral view confirm nail position by observing the notch present at the nail drill guide junction Each gauge on the insertion barrel represents a 10mm depth interval If compression or dynamic locking is desired it is recommended to countersink the nail approximately 10mm in order to avoid implant prominence Distal In the AP and lateral views confirm that the nail has been inserted to the desired depth Distal third tibial fractures require at least three locking screws to maintain stability so optimal insertion depth is essential Remove the Guide Rod on
29. ge Tips tricks and important information appear in blue Indications contraindications intended use and training The Smith amp Nephew TRIGEN SURESHOT Distal Targeting System is intended to be an intraoperative image guided localization system It is a computer assisted orthopaedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation It provides information to the surgeon that is used to place surgical instruments during surgery utilizing intraoperatively obtained electromagnetic tracking data The Smith amp Nephew TRIGEN SURESHOT Targeting System V2 0 is indicated for long bone fractures treated with intramedullary nails in which the use of stereotactic surgery may be appropriate An example of a surgical procedure includes but is not limited to locating and drilling the distal holes in an intramedullary nail Contraindications The screw targeting software application for this system is contraindicated for all IM nails other than Smith amp Nephew TRIGEN META NAIL FAN Pediatric and Adolescent nails Do not operate the TRIGEN SURESHOT Targeter within 200mm of an installed pacemaker The magnetic field produced by the Targeter may interfere with the operation of the pacemaker Intended use The TRIGEN SURESHOT Distal Targeting System is only designed for use with the indicated implants and instruments Implants and instruments must be used in accordance with the instr
30. he Guide Wire through the Entry Tube to a depth of 4 6cm Maintain alignment so as to avoid penetration of the posterior cortex Check position via radiographic imaging and then remove the 12 5mm Entry Reamer and 3 2mm Tip Threaded Guide Wire Alternative technique Entry portal gt Attach the T handle 7167 4076 to the Cannulated Awl 7167 4000 and insert into the proximal tibia to a depth of 4 6cm Introduce the 3 2mm T handle Trocar 7167 4074 into the back of the assembly prior to insertion in order to prevent awl slippage and accumulation of cortical bone within the cannulation Cannulated Awl 3 2mm T handle with T handle Trocar Instruments for fracture reduction and reaming OD Entry Portal Tube Cat No 7167 4060 P c B Ruler Cat No 167 4079 T handle Cat No 167 4076 Reamer Heads Cat No 7111 8231 8246 Entry Portal Handle Cat No 7167 4092 Gripper Cat No 7167 4080 Obturator Cat No 7167 4078 Flexible Reamer Shaft Cat No 7111 8200 Reducer Cat No 7167 4077 a 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 15 Fracture reduction Insert the back end of the 3 0mm Ball Tip Guide Rod 163 1626 into the front of the Gripper 167 4080 and gently close the trigger grip Connect the Reducer and Reducer Connector 167 4077 so that the words Slot Orientation are in line with the opening at the tip Complete the assembly
31. he thumb wheel connection at the end to allow for free movement Unreamed technique Radiographic templating is used to determine nail size The appropriate diameter implant will provide translational fill within the isthmus of the intramedullary canal Generally selection of a nail approximately 1 1 5mm less than the narrowest canal measurement on the lateral radiograph assists in avoiding implant incarceration during insertion 18 60mm 50mm 40mm 30mm 20mm 10mm Top of Nail S en SD SOW LATERAL VIEW Shaft Diameter O i VIEW Template 25mm mU 2 TN 35mm ur 40mm 45mm 50mm 55mm a 60mm 65mm 70mm 75mm iV UAM 80mm 85mm M 90mm 95mm uf 100mm 105mm u 1l0mm 5 0mm Gold Screw 25mm 30mm 35mm 40mm 45mm 50mm 55mm 60mm 65mm 4 5mm Grey Screw used w 8 5mm nail only Size Set Screw Nail Cap Size Nail Cap 20mm n mm 15mm 10mm k 5mm l Nail Cap TRIGEN META NAIL Tibial Nail Radiographic Template Cat No 7118 0810 Reamed technique Radiographic templating and intraoperative measurement will determine nail size Beginning with the 9 0mm Front Cutting Reamer Head 111 8231 and Flexible Reamer Shaft 111 8200 ream the intramedullary canal sequentially in half millimeter increments to a size 1 1 5mm larger than the selected nail size Ensure guide rod placeme
32. ion barrel matches the line of the nail 2 The A on the nail matches the A on the insertion barrel 3 The apex of the nail s proximal Herzog Bend faces posterior and the drill guide is oriented anterior The bevel on the front of the nail marks the connection to the drill guide and can be seen in the lateral view as a means for determining proximal insertion depth Note It is recommended to use the standard drill guide and Guide Bolt Long for compression or dynamic locking as the longer insertion barrel facilitates countersinking of the nail Note The assembly and insertion of the grey 8 5mm diameter META NAIL Tibial Nail follows the same technique as the 10mm 11 5mm and 13mm diameter nails Attach the Anterior Drop 7165 4501 to the drill guide and verify targeting accuracy by inserting a gold 9 0mm Drill Sleeve 7163 1152 and silver 4 0mm Drill Sleeve 7167 4083 into the Drop and passing a 4 0mm Long Pilot Drill 163 1110 through the assembly An incorrectly attached nail will not target Note See page 25 for the field accuracy check with the TRIGEN SURESHOT Distal Targeting System 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 21 3 System setup Connect probe to Trauma Interface unit Make T sure to use the adequate probe with the correct nail color coded Connect the probe to either of the probe sensor ports on the Trauma Interface
33. lignment Tighten the device to the awl and insert the appropriate Blocking Screw Cartridge 165 4511 7165 4513 7165 4514 Adjust the Cartridge proximally or distally within the Blocking Screw Device to determine blocking screw position Insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve into the desired cartridge hole and down to bone Drill both cortices with the 4 0mm Long Pilot Drill Screw length is determined by reading the exposed drill bit calibrations or by removing the 4 0mm Drill Sleeve and measuring with the Screw Depth Gauge Insert the screw with the Medium Hexdriver T handle assembly until the screw engages the far cortex Note Use caution during drilling and insertion of blocking screws in the AP plane Plunging the drill bit past the posterior cortex or insertion of a screw that is too long may damage the neurovascular structures located posterior to the proximal tibia 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 46 Following implantation of the proximal blocking screw and fracture reduction pass the 11 0mm T handle Awl into the distal fragment Reposition either the Blocking Screw Cartridge or the awl as necessary and follow the previously described technique for blocking screw insertion ML blocking screw insertion In order to prevent anterior or posterior malalignment of the proximal fragment blocking screws may also be place
34. mensions Degree of Distal Bend 22 28 Distal Bend Location 60mm 60mm Set does not include all sizes Outlier sizes may be special order only Most distal hole threaded Surgical technique Patient positioning Position the patient supine on a radiolucent table with the unaffected limb extended away from the affected limb Alternatively a fracture table may be used with a pin inserted through the calcaneus to place the leg in traction Flex the affected limb 80 90 and check for length and rotation by comparison to the unaffected limb Use a bolster or radiolucent triangle to maintain limb position Rotate the C Arm to ensure optimal AP and lateral visualization of the entire tibia A distraction device may also be applied to obtain and or maintain traction Caution Do not use a metal bump because it will adversely affect the accuracy of the TRIGEN SURESHOT system Warnings and cautions for TRIGEN SURESHOT Accessibility of documentation Please ensure that all instructions are kept in an easily accessible place for operating personnel The operator checks and decides All the information provided by the TRIGEN SURESHOT Distal Targeting System is to help the operator make decisions during the operation The operator must check all the suggestions made by the system and is responsible for all decisions taken Responsibility of Smith amp Nephew Orthopaedics In the event of improper use Smith amp Nephew ac
35. nail Adjust probe to nail length Skin incision Use serrated tip of Drill Sleeve to identity where to make incision The tip is at the right position when the green circle is aligned with the desired hole on screen Make incision and place tip of the drill sleeve down to bone where the green circle is aligned directly over the hole on screen Note No X Rays necessary 30 u blia 10 mm Short Sleeve Targeting the locking hole With the appropriate length TRIGEN SURESHOT 4 0mm Drill Bit 169 2810 or 7169 2811 inserted into the Targeter insert the tip of the drill sleeve represented by the green circle through the incision and down to bone Critical Verify there are no other metal objects including metal triangles in the field Metal interference will cause the system to be inaccurate Perfect circles Align the tip of the drill sleeve over the desired hole in the nail This will be represented on the screen when the green circle is centered in the hole as shown Push serrated tip firmly against bone to keep the green circle static on the screen Note The orientation of the view is determined based on the orientation of the Targeter relative to the implant For example if the desired hole to target is an AP hole direct the Targeter generally on the Anterior side of the leg For more options please see section Trauma Interface Screen Operation Adjust the trajectory represented by red lin
36. nt during reaming by inserting the Obturator into the back of the Reamer unit during retraction Continue to confirm Guide Rod placement in the distal tibia throughout reaming Periodically move the reamer back and forth in the canal to clear debris from the cutting flutes Instruments for nail assembly and insertion Guide Bolt Wrench Cat No 7163 1140 META NAIL Drill Guide Cat No 7165 4502 Extension Guide Bolt Cat No 7165 4505 Cannulated Impactor Short Cat No 7165 4554 T handle Cat No 7167 4076 META NAIL Anterior Drop Cat 7165 4501 9 0mm Drill Sleeve Cat No 7163 1152 META NAIL Extension Drill Guide Cat No 7165 4503 n F S 4 0mm Drill Sleeve Cat No 7167 4083 Note TRIGEN SURESHOT cannot be used with ee eer this guide 4 0mm Long Pilot Drill Cat No 7163 1110 na Guide Bolt Long Cat No 7165 4506 Cannulated Impactor Medium Cat No 7167 5081 Slotted Hammer Cat No 7167 4082 META Set Stop Cat 7169 2806 META NAIL Standard Drill Guide Probe Cat No 7169 2814 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 163 1121 20 Nail assembly Attach the META NAIL Drill Guide 7165 4502 to the nail with the Guide Bolt Long 7165 4506 and tighten with the Guide Bolt Wrench 163 1140 and T handle The nail is correctly aligned when 1 The line on the insert
37. on and use the long drill bit 42 Problem Red and Green targeting circles representing the drill sleeve appear incorrect Targeting missed the intended hole Drill sleeve cannot be removed from TRIGEN SURESHOT Targeter The 4 7mm 4 0mm step drill will not fit through the drill sleeve Field Accuracy Check fails Possible cause Incorrect drill sleeve length selected Metal interference within the SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Metal interference within the TRIGEN SURESHOT electromagnetic field Probe not inserted correctly within set stop Damaged probe Over tightening of drill sleeve Not compatible with the TRIGEN SURESHOT Distal Targeting System Metal interference within the TRIGEN SURESHOT electromagnetic field Field Accuracy Gauge improperly installed on Targeter META Set Stop improperly installed on Field Accuracy Gauge Probe is incorrectly inserted within META Set Stop Probe is damaged Targeter is damaged Suggested action Verify the correct drill sleeve length is selected trom the software menu Remove any metal objects from the targeting field Verify probe is oriented and seated correctly in the notches of the set stop Verify probe accuracy with Field Accuracy Gauge Remove any metal objects from the targeting field Verity probe is oriented and seated correctly in the notches of the se
38. op from the Targeting System cannot be used with the drill guide if overtightened META NAID Extension Drill Guide 7165 4503 Ensure that the probe is oriented correctly and the set stop position and IM nail length match Note Verify the set stop position and nail length match align the drill sleeve with one of the distal holes of the nail Verify on the display that the representation of the nail drill sleeve is true Remove the probe from inside the nail and begin nail insertion Take off set stop before inserting the nail and place the impactor Note Verify the probe is oriented correctly in the set stop notches should face anteriorly If the probe is rotated 180 it will not be accurate Note The probe is bent for easier insertion Do not straighten it as this may cause inaccuracy or even missing the lock Note All tool cables should be uncoiled completely and any excess cables should be kept out of the Targeter measurement volume Note To guarantee system accuracy the accuracy check has to be performed directly in the operative field 24 lt N 3 Field accuracy check Optional A field accuracy check procedure should be performed at least once a year or whenever the accuracy of a TRIGEN SURESHOT probe or TRIGEN SURESHOT Targeter needs to be verified This procedure can also be performed during surgery to verify all components are working correctly prior to their use on a patient Field ac
39. ousing or the connector is damaged the Targeter is no longer safe to use Note If the Targeter is not recognized after connection to the system the Targeter is defective and must be exchanged See also instrument connection Note Broken or damaged instruments must be exchanged immediately and sent back to Smith amp Nephew Inc Note This device is provided non sterile and must be cleaned and sterilized per Cleaning and Sterilization Smith amp Nephew document 7138 1339 prior to use Surgical procedure OR preparation Note This procedure will cover only the specific steps of freehand targeting of intramedullary locking holes using the TRIGEN SURESHOT Distal Targeting System For the full surgical procedure please refer to the specific surgical technique for the TRIGEN IM Nail System being implanted Trauma Interface setup After the sterile areas have been established place the Trauma Interface 7169 2802 in the desired non sterile location and turn on the power switch Pressing the power button will bring up the start up screen Menu Starting up SURESHOT Targeting TRIGEN SURESHOT Targeter connection When the display prompts for tool connections connect the TRIGEN SURESHOT Targeter 7169 2801 to the Targeter port on the Trauma Interface Tip If the Trauma Interface does not power on make sure the switch is in the on position Note No other electrical devices should be
40. placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table contained in Smith amp Nephew document 7118 1540 Note The Targeter body may have contact with the patient and must remain in the sterile field at all times Only the cable and connector may be removed from the sterile field Note This step needs to be performed at least ten minutes prior to targeting in order to ensure proper accuracy Tip When oriented as shown the connector should assemble easily Do not force the connector into the port Note If the Targeter is properly connected to the system and the application remains in this screen for more than 30 seconds the Targeter may have been damaged during cleaning sterilization In this case another Targeter has to be used Tip It is possible at any time to disconnect and reconnect tools when the application is running The display will show a screen reporting the missing instrument Targeter and probe have not been connected Menu SURESHOT Probe SURESHOT Targeter not found not found Confirmation that the Targeter tool has been connected when the center of the Targeter lights up orange SURESHOT Targeter connected Instruments for opening the proximal tibia 3 2mm Tip Threaded Guide Wire Mini Connector Cat No 7163 1690 Cat No 7163 1186 12 5mm Entry Reamer Cat No 7163 1116 Honeycomb Cat No 7167 4075 T handle Cat
41. r Cat No 7163 1186 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 44 Blocking screw technique Incision and entry point A 2cm incision is made in line with the intramedullary canal This may be patellar splitting medial or lateral parapatellar in its orientation The entry point is located just medial to the lateral tibial eminence in the AP view and in line with the anterior cortex and intramedullary canal in the lateral Entry portal acquisition Insert the 11 0mm T handle Awl 7165 4522 manually to a depth just proximal to the fracture Note When creating the initial entry point pay close attention to the trajectory of the awl and the relationship to the anatomic axis of the tibia Correct awl trajectory in the proximal fragment must be established prior to alignment with the anatomic axis of the distal fragment This will ensure accurate fracture reduction when the nail is inserted 45 AP blocking screw insertion In order to prevent varus or valgus malalignment of the proximal fragment blocking screws may be placed in the AP plane Attach the Blocking Screw Device 7165 4515 to the 11 0mm T handle Awl and move it into the desired position in the AP plane Note The Blocking Screw Alignment Pins 165 4523 can be screwed into the three 3 threaded holes on the metal handle of the Blocking Screw Device to serve as external points of reference during fracture a
42. t stop Verify probe accuracy with Field Accuracy Gauge Use the Slotted Hammer from the instrument tray as a wrench to unscrew the drill sleeve counter clockwise from the Targeter Only use the long 7169 2811 and short 7169 2810 drills designated for use with the TRIGEN SURESHOT Distal Targeting System Remove any metal objects from the targeting field Verity Field Accuracy gauge is fully seated within Targeter port and knob is hand tightened to Targeter Verify META Set Stop is correctly oriented and tightened securely to Field Accuracy Gauge Verity probe is oriented properly and inserted to the REF notches on probe body Replace probe with a new probeVW Replace Targeter with a new Targeter and return old one for service 43 Instruments for blocking screw insertion 8 5mm 10 0mm 11 5mm 13 0mm Offset Blocking Screw Cartridge Screw Cartridge Screw Cartridge Cat No 7165 4511 Cat No 7165 4513 Cat No 7165 4514 Tibia Blocking Screw Attachment Blocking Screw Alignment Pin Cat No 7165 4509 Cat No 7165 4523 11 0mm T handle ee 9e44952995945659444499 Awl 4 0mm Long Pilot Drill Cat No 165 4522 Cat No 7163 1110 Blocking Screw Device Cat No 7165 4515 4 0mm Drill Sleeve Cat No 7163 1156 S OS T handle Cat No 7167 4076 9 0mm Drill Sleeve Cat No 7163 1152 Medium Hexdriver Cat No 7163 1066 Mini Connecto
43. th 8 5mm diameter nails Note Do not use the 4 0mm Short Step Drill 164 1123 when drilling for a grey 4 5mm locking screw Its diameter transitions from 4 0mm to 4 7mm and will drill too large a hole in the near cortex This may compromise locking screw purchase 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 4 0mm Short Drill 7163 1117 is interchangeable with 4 0mm AO Short Drill 7163 1123 35 Note Make sure to remove probe before proximal locking Proximal locking Static Make a small incision at the site of screw entry and insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve through the static slot on the Anterior Drop down to bone Drill both cortices with the 4 0mm Long Pilot Drill Measure for screw length using either the calibrations on the 4 0mm Long Pilot Drill or by removing the 4 0mm Drill Sleeve and using the Screw Depth Gauge Attach the appropriate length screw to the end of the Medium Hexdriver 7163 1066 and insert through the gold 9 0mm Drill Sleeve on power until the laser etched ring on the Hexdriver reaches the back of the Drill Sleeve Attach the T handle to the Hexdriver and tighten the screw by hand Proximal locking Dynamic With the nail countersunk approximately 10mm make a small incision at the site of screw entry and insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve through the dynamic slot on the Anterior
44. the Nail Cap Set Screw 7165 6000 into the top of the nail and advance with the Medium Hexdriver T handle assembly until the fracture is compressed and the Nail Cap Set Screw has fully engaged the locking screw Note If the Compression Driver is progressed after the fracture is fully compressed then the locking screw will begin to bend In extreme cases where excess force is applied the screw may break upon removal 37 Trauma Interface screen operation Overview mode eu When the Targeter is greater than 5cm from the interlocking holes the Trauma Interface screen will display the IM nail in the overview mode This provides the user with a larger field of view in order to help find the general location of the interlocking holes The view in the upper right corner is the profile view It is collinear to the drill sleeve axis and the position is aligned with the tip of the drill sleeve Drilling mode UU When the Targeter is moved within 5cm of the interlocking holes the Trauma Interface screen will display the IM nail in the drilling mode This provides the user with a smaller field of view that automatically zooms in to the interlocking holes The white lines displayed on either side of the IM nail can be used for targeting blocking screws These lines are located 2 5mm from the side of the IM nail for all IM nails 10mm and larger in diameter These lines are located 2mm from the sides of 8 5mm IM nails
45. uctions as described in this manual and or in the non navigated surgical procedure Training Only trained operators are allowed to use the TRIGEN SURESHOT Distal Targeting System The various operating instructions must be fully read and understood as part of the training If any part of the instructions is unclear please contact your local representative Plausibility check As with all technical equipment malfunctions may occur due to improper use or more rarely technical failure To reduce the risks involved with such technical malfunction the operation can be completed using manually controlled instruments providing the malfunction is detected without delay It is therefore important to check the plausibility of the steps as indicated by the system and to carry out verification of the software targeting particularly when using the system for the first time Should there be any doubt regarding correct functioning the targeting should be verified or a switch made to a traditional X Ray technique TRIGEN 10 60mm META NAIL Tibial Nail specifications Driving end of nail all knee and distal tibial Top view of nail TRIGEN META NAIL Tibia Specifications TRIGEN META NAIL Tibia 8 5mm Material Diameter Lengths Nail Color Cross Section Proximal Diameter driving end Distal Diameter non driving end Smallest Thru Diameter Wall Thickness Guide Bolt Thread Screw Di
46. uide Cat No 7165 4503 Extension Guide Bolt 23mm Cat No 7165 4505 Guide Bolt Long 51mm Cat No 7165 4506 META NAIL Instrument Case Cat No 7165 4551 META NAIL Instrument Lid Cat No 7165 4550 Long Screw Length Sleeve Cat No 7165 4520 Cannulated Impactor Short Cat No 7165 4554 58 Instruments used if you have TRIGEN Base Set Set No 7167 4012 Medium Hexdriver Cat No 7163 1066 Short Hexdriver Cat No 7163 1068 12 5mm Entry Reamer Cat No 7163 1116 Guide Bolt Wrench Cat No 7163 1140 9 0mm Drill Sleeve Cat No 7163 1152 Multipurpose Driver Cat No 7163 1161 Mini Connector Cat No 7163 1186 Screw Depth Gauge Cat No 7163 1189 Cannulated Awl Cat No 7167 4000 Entry Portal Tube Cat No 7167 4060 3 2mm T handle Trocar Cat No 7167 4074 Honeycomb Cat No 7167 4075 Flexible Reamer Shaft Cat No 7111 8200 Reamer Heads Cat No 7111 8231 8246 59 Catalog information TRIGEN META NAIL Instruments T handle Cat No 7167 4076 Reducer Cat No 7167 4077 Obturator Cat No 7167 4078 Ruler Cat No 7167 4079 Gripper Cat No 7167 4080 Cannulated Impactor Medium Cat No 7167 5081 Slotted Hammer Cat No 7167 4082 4 0mm Drill Sleeve Cat No 7167 4083 Screwdriver Release Cat No 7167 4084 Screw Length Sleeve Cat No 7167 4085 Entry Portal Handle Cat No 7167 4092 60 Instruments used if you
47. urate functionality the device should be checked per the Maintenance Instructions contained in a separate Smith amp Nephew document 7118 1540 This accuracy check must be performed at least once every 12 months If this accuracy check is not performed as defined in the previous paragraph all warranty claims expire and the device is operated at the user s own risk Recycling Old electrical and electronic equipment must be disposed separately and may not be included in the regular domestic waste Alternatively the unit can be handed over to Smith amp Nephew Orthopaedics for correct recycling Note Do not unplug the power while the system is running Note Danger of damage and tipping over Tip Place the unit on a firm level surface capable of holding at least 10kg 22 lbs Note To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth Devices for system set up 2 4 oem gt smith amp nephew TRIGEN SURESHOT Distal Targeting System a Trauma Interface Cat No 7169 2802 Power Cord Cat No 6680 0193 SURESHOT Targeter Cat No 169 2801 Note The Targeter will be operated within the sterile field and may have contact with the skin of the patient The drill sleeve inserts will be used in the incision and have direct bone contact Note Verify that the Targeter housing is not damaged holes tears cracks If the h
48. xtractor 7163 1320 is interchangeable with the Large Nail Extractor 7163 1278 located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 62 Catalog information TRIGEN SURESHOT Instruments TRIGEN SURESHOT Targeting Interface Cat No 7165 7000 Cat No Device Case Qty 7169 2802 Trauma Interface TRIGEN SURESHOT Targeting Instrument Set Set No 7165 7001 Cat No Description Tray Qty 7169 2801 Targeter 1 7169 2804 Drill Sleeve Long 2 7169 2805 Drill Sleeve Short 2 7169 2806 META Set Stop 1 1 1 1 1 1 1 7169 2807 Set Stop 7169 2808 Field Accuracy Gauge 7169 2809 Hexdriver 7169 2816 TAN Anteversion Locking Guide 7169 2830 Targeting Instrument me M pr 7169 283 Targeting Instrument Tray Lid TRIGEN SURESHOT Targeting Disposables Set Set No 7165 7002 Cat No Description Qty 7169 2810 AO Drill Bit Short 2 7169 2811 AO Drill Bit Long 1 Additional Disposables Cat No Description 7169 2803 META NAIL Semi Extended Drill Guide Probe used with META NAIL Semi Extended a nn o U cdd Instrument Set 7165 4004 7169 2814 META NAIL Standard Drill Guide Probe used with TPIGEN META NAIL Nail Instrument Ll UUULUIL ai Set 7165 4002 7169 2815 Percutaneous TAN FAN Drill Guide Probe ws used with TRIGEN Percutaneous TAN FAN m Instrument Set 7163 2351 63 Catalog information TRIGEN
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