Including - Smith & Nephew
Contents
1. nennen 5 Guide rod jamming technique sss 52 e c Ansm ulm 53 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 TAN and FAN intramedullary nails are indicated for fractures of the femur including intertrochanteric basi transcervical femoral neck fractures and subtrochanteric fractures ipsilateral femoral neck shaft fractures stable and unstable shaft fractures segmental fractures nonunions and malunions polytrauma reconstructions following tumor resection and bone lengthening and shortening TRIGEN SURESHOT indications Legend Important warnings appear in orange 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 electromagneti2. uu Each 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 TRIGEN META NAIL shown the view in a clockwise or counterclockwise direction To flip the view 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 Menu Options Menu Tapping on the Menu button will open up several Menu options Toggle back view 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 e 45 46 Drill sleeve Tap on screen to select appropriate drill sleeve Field check Fail screen meaning that something is not targeting correctly See Troubleshooting section for further information Pass screen When targeting correctly a pass screen will occur
3. specifications From bone shaft centerline Standard Femoral Lock 130 standard FAN Exchange Recon Lock 12 Anteversion 130 standard FAN Exchange Distal Lock 130 standard FAN Exchange Proper Screw Measurement All TRIGEN locking screw measuring devices measure from bottom of head to the last complete thread of screw This is the working length of the screw Thus the screw itself is longer than the measurement and adding length is not necessary Note These views are not to scale and should be used as a pictorial representation only Specifications TRIGEN FAN Nail Material Diameter Lengths Nail Color Left Nail Color Right Cross Section Neck Angle Proximal Diameter driving end Distal Diameter non driving end Smallest Thru Diameter Wall Thickness Guide Bolt Thread Alternative Guide Bolts Removal only Alternative Modes TI6AL4V 10 11 5 13 14 5 amp 16mm 30 50cm 36 44 Lime Rose Round 130 13mm 10 11 5 amp 13 diameter 14 5mm 14 5 diameter 16mm 16 diameter 10 11 5 13 14 5 amp 16mm diameter of the nail 5 4mm 2 3mm 10 diameter 3 0mm 11 5 diameter 2 3mm 13 diameter 2 3mm 14 5 diameter 2 4mm 16 diameter 5 16 24 RT Tibial Retrograde IMSC Revision Standard Femoral Recon Locking Proximal Locking Screw Diameter Major Diameter Minor Diameter Shank Hex Size Alternative Hexdrivers Screw C
4. Preoperative Template Cat 7118 0884 Preoperative Template Cat No 7118 0497 Instruments for assembly insertion AP Alignment Arm Cat No 7163 1015 Percutaneous Guide Bolt Cat No 7163 1024 AP Alignment Tower Cat No 7163 1025 Percutaneous Drill Guide Cat No 7163 1021 2 4 Cat No 7167 4076 Slotted Hammer Cat No 7167 4082 Guide Bolt Wrench Cannulated Impactor Medium Cat No 7163 1140 Cat No 7167 5081 9 0mm Drill Sleeve 4 0mm Trocar Drill Sleeve Cat No 7163 1152 Cat No 7163 1026 6 4mm Step Drill Radiolucent Drop Cat No 7163 1160 Cat No 163 1022 4 0mm Long Pilot Drill Cat No 7163 1110 4 ER m ISP 5 AO Drill Bit Long TAN Anteversion Locking Guide Cat No 7169 2811 pictured with drill Cat No 7169 2816 Percutaneous TAN FAN Drill Guide Probe Cat No 7169 2815 TAN Set Stop Cat No 7169 2807 The Cannulted Impactor Medium 7167 5081 is interchangeable with the Cannulated Impactor Long 7163 1185 4 0mm AO Long Drill 7163 1121 is interchangeable with 4 0mm Long Pilot Drill 7163 1110 23 assembly Attach the Percutaneous Drill Guide 7163 1021 to the nail with the Percutaneous Guide Bolt 7163 1024 and tighten with the Guide Bolt Wrench 7163 1140 and T handle 7167 4076 The nail is correctly aligned when 1 The apex of the nail s AP
5. Orders Inquiries 1 800 238 7538 The color Pantone 151 Orange for medical instruments is a US registered trademark of Smith amp Nephew 2012 Smith amp Nephew Inc All rights reserved Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM Off 7118 1611 REVA 04 12
6. 6 4mm Standard 4 3mm Recon 4 7mm N A Recon 6 3mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC Locking Screw Guide Standard Lock Gold Recon Lock Blue Standard 25 110mm Recon 65 125mm Recon Lock 12 21 33 amp 47mm No Standard 5 3mm Recon 6 4mm 5 lateral 65mm AP bend Distal Locking Screw Diameter Major Diameter Minor Diameter core Screw Color Screw Lengths Location Orientation Dynamization Slot Distal Screw Hole Dimensions AP Bow Location of Distal Bend Dynamization Slot Location 5 0mm 5 0mm 4 3mm Gold 25 110mm 15 20 amp 40mm L M Yes 5 3mm Proximal 1 5 meters Distal 2 5 meters 100mm Distal Design features 130 Femoral and Recon gt lt Straight screw angles proximal profile for ease P dd Unique five hole of insertion 12 of built in femoral proximal locking through the configuration allows piriformis fossa femoral or recon neck anteversion for optimal proximal screw position locking modes in one nail Hybrid proximal distal AP Color coded Bow transition 1 5m 2 5m Lime left Rose right lt Cannulated round geometry for ease of insertion using reamed or unreamed technique lt Static and dynamic distal locking configuration using 5 0mm TRIGEN Internal Hex Captured Locking Screws TRIGEN Femoral Antegrade
7. 7163 4234 7163 4236 7163 4238 7163 4240 Right Rose 7163 5230 763 5232 7163 5234 7163 5236 763 5238 7163 5240 Length Neck Angle 30 130 32 130 34 130 36 130 38 130 40 130 11 5mm Diameter Nails 30cm 50cm Left Lime 7163 4330 7163 4332 7163 4334 7163 4336 7163 4338 7163 4340 Right Rose 7163 5330 763 5332 7163 5334 7163 5336 7163 5338 7163 5340 Length Neck Angle 30 130 32 130 34 130 36 130 38 130 40 130 13mm Diameter Nails 30cm 50cm Left Lime 7163 4430 7163 4432 7163 4434 7163 4436 7163 4438 7163 4440 Right Rose 7163 5430 7163 5432 7163 5434 7163 5436 7163 5438 7163 5440 Length Neck Angle 30 130 32 130 34 130 36 130 38 130 40 130 14 5mm Diameter Nails 36cm 44cm Left Lime 7164 4536 7164 4538 7164 4540 Right Rose 7164 5536 7164 5538 7164 5540 Length Neck Angle 36 130 38 130 40 130 16mm Diameter Nails 36cm 44cm Left Lime 7164 4636 7164 4638 7164 4640 Right Rose 7164 5636 7164 5638 7164 5640 Length Neck Angle 36 130 38 130 40 130 Contained in the standard implant set Left Lime 7163 4242 7163 4244 7163 4246 7163 4248 7163 4250 Left Lime 7163 4342 7163 4344 7163 4346 7163 4348 7163 4350 Left Lime 7163 4442 7163 4444 7163 4446 7163 4448 7163 4450 Left Lime 7164 4542 7164 4544 Left Lime 7164 4642 7164 464
8. 7240 7164 7242 7164 7244 7164 7246 7164 7248 7164 7250 Right Rose 7164 8230 7164 8232 7164 8234 7164 8236 7164 8238 7164 8240 7164 8242 7164 8244 7164 8246 7164 8248 7164 8250 Length 30 92 34 36 38 40 42 44 46 48 50 Neck Angle 130 130 130 130 130 130 130 130 130 130 130 11 5mm Diameter Nails 30cm 50cm Left Lime 7164 7330 7164 7332 7164 7334 7164 7336 7164 7338 7164 7340 7164 7342 7164 7344 7164 7346 7164 7348 7164 7350 13mm Diameter Nails Left Lime 7164 7430 7164 7432 7164 7434 7164 7436 7164 7438 7164 7440 7164 7442 7164 7444 7164 7446 7164 7448 7164 7450 Right Rose 7164 8330 7164 8332 7164 8334 7164 8336 7164 8338 7164 8340 7164 8342 7164 8344 7164 8346 7164 8348 7164 8350 Right Rose 7164 8430 7164 8432 7164 8434 7164 8436 7164 8438 7164 8440 7164 8442 7164 8444 7164 8446 7164 8448 7164 8450 Length Neck Angle 30 130 32 130 34 130 36 130 38 130 40 130 42 130 44 130 46 130 48 130 50 130 30cm 50cm Length Neck Angle 30 130 32 130 34 130 36 130 38 130 40 130 42 130 44 130 46 130 48 130 50 130 Contained in the standard implant set 55 Catalog information TRIGEN and FAN Implants TRIGEN Femoral Antegrade Nails Set 7163 1337 10mm Diameter Nails 30cm 50cm Left Lime 7163 4230 7163 4232
9. No Description Qty 6680 0303 Power Cord 250 Volt 10 1 Australia NZ 7118 1927 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 1927 User Manual English 1 TRIGEN SURESHOT Country Kit Germany Cat No 7165 7006 Cat No Description Qty 6680 0291 Power Cord 250 Volt 10 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 59 60 Catalog information TRIGEN SURESHOT Instruments 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 ltalian 1 TRIGEN SURESHOT Country Kit United Kingdom Cat No 7165 7011 Cat No Description Qty 6680 0213 Power Cord 250 Volt 10 Amp UK 1 7118 1927 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 1927 User Manual English 1 Smith amp Nephew Inc www smith nephew com 7135 Goodlett Farms Parkway Cordova TN 38016 USA Telephone 1 901 396 2121 Information 1 800 821 5700
10. 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 4 0mm AO Short Drill 7163 1123 is interchangeable with 4 0mm Short Drill 7163 1117 42 Closure Obtain final AP and lateral radiographic images to confirm implant position and fracture reduction Closure follows standard technique 43 44 Trauma Interface screen operation E Tr Overview mode 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 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 Drilling mode manual rotation
11. Portal Handle Cannulated Impactor Medium Tray Qty lea lea lea lea lea ea 2 ea ea lea ea ea 53 Catalog information Instruments TRIGEN Percutaneous FAN Instrument Set Set No 7163 2351 Instrument Case Cat No Description 7163 1027 Percutaneous Instrument Tray 7163 1028 Percutaneous Instrument Lid Instruments Cat No Description 7163 1021 Percutaneous Drill Guide 7163 1022 Radiolucent Drop 7163 1039 14mm Channel Reamer 7163 1024 Percutaneous Guide Bolt 7163 1036 Sterile 6 4mm Tap Disposables Set No 7163 1000 Cat No Description 7163 1035 Sterile 6 4mm Drill 7163 1320 TRIGEN Disposable Nail Extractor 7163 1121 4 0mm Long AO Pilot Drill Tray Qty 1 ea 2 Qty lea 1 ea 2ea Cat No 7163 1026 7163 1191 7163 1025 7163 1015 Cat 7163 1123 7163 1626 7167 4130 Description 4 0mm Trocar Drill Sleeve 4 0mm Trocar AP Alignment Tower AP Alignment Arm Description 4 0mm Short AO Pilot Drill 3 0mm X 1000mm Ball Tip Guide Rod 3 2mm X 343mm Tip Threaded Guide Pin Tray Qty 2 ea 1 ea 1 ea Qty 2 2 3 ea Catalog information and FAN Implants TRIGEN Trochanteric Antegrade Nails Set No 7163 1236 10mm Diameter Nails 30cm 50cm Left Lime 7164 7230 7164 7232 7164 7234 7164 7236 7164 7238 7164
12. bow points anterior 2 The three proximal locking holes on the lateral side of the nail mirror the image depicted on the underside of the drill guide Example For left 130 TAN orient the drop on the drill guide so that the two lime colored arrows indicating 130 TAN on its surface point towards the nail The Smith amp Nephew mark on the drop will face laterally Note See page 28 for the field accuracy check with the TRIGEN SURESHOT Distal Targeting System 24 System setup Connect probe to Trauma Interface unit Make 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 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 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 sterile by ethylene oxide gas and is single use Green probe connector into the port Use only with Percutaneous TAN FAN Drill Guide 7163 1021 There will confirmation the screen of the Menu Trauma Interface that implies that the probe has been conn
13. in the operative field Note The TRIGEN SURESHOT Distal Targeting System cannot be used with the Standard TRIGEN Drill Guide 7163 1134 2 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 accuracy check steps Attach TRIGEN SURESHOT Field Accuracy Gauge 7169 2808 to TRIGEN SURESHOT Targeter The knob on the Field Accuracy Gauge should be hand tightened only N Attach the TRIGEN SURESHOT META Set Stop 7169 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 0 Check option 28 4 software window will appear informing the user if the TRIGEN SURESHOT Targeter and Probe combination is within the predefined accuracy parameters Pass or Fail message 5 If the field accuracy check fails check the 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 29 1 Femoral locking mode
14. 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 probe 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 femur i 3 2mm x 343mm Brad Point Drill Tip Threaded Guide Pin Cat No 7167 4130 Mini Connector Cat No 7163 1186 Honeycomb Entry Portal Tube Entry Portal Handle Cat No 7167 4075 Cat No 7167 4060 Cat No 7167 4092 12 5mm Entry Reamer 14mm Channel Reamer Cat No 7163 1116 Cat No 7163 1039 3 2mm T handle Trocar Cat No 7167 4074 Cat No 7167 4076 Cannulated Awl Cat No 7167 4000 Incision entry point Assemble the Honeycomb 7167 4075 Entry Portal Handle 7167 4092 and Entry Portal Tube ummm 7167 4060 The pieces will lock in place securely at either 0 or 180 A longitudinal incision is made proximal to the greater trochanter Carry the incision through to the fascia and palpate the tip of the greater trochanter The optimal e
15. 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 line 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 35 Drilling distal hole Drill through near cortex and the nail using the TRIGEN SURESHOT 4 0mm Drill Bit 7169 2810 or 7169 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 The standard 4 0mm drill cannot be used with the TRIGEN SURESHOT system 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 sleev
16. 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 are IEC60601 1 approved and which are approved by Smith amp Nephew 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 accurate functionality the device should be checked per the Maintenance Instructions contained in a separate Smith amp Nephew document 7118 1927 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 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 leve
17. 000 0mm 7163 4015 15mm 1 7163 4005 5mm 7163 4020 20mm H j 1 Wi 7163 4010 10mm Contained in the standard implant set 58 Catalog information IRIGEN SURESHOT Instruments TRIGEN SURESHOT Targeting Interface Cat No 7165 7000 Cat No Device Case Qty 7169 2802 Trauma Interface 1 TRIGEN SURESHOT Targeting Instrument Set Set No 7165 7001 Cat No Description Tray Qty 7169 2801 Targeter 7169 2804 Drill Sleeve Long 7169 2805 Drill Sleeve Short 7169 2806 META Set Stop 7169 2807 Set Stop 7169 2808 Field Accuracy Gauge 7169 2809 Hexdriver 7169 2816 TAN Anteversion Locking Guide 7169 2830 Targeting Instrument Tray m Lac de G lt BDE n GE LOMA mus eo 7169 2831 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 Disposable Cat No Description 7169 2815 Percutaneous TAN FAN Drill Guide Probe used with TRIGEN Percutaneous _ Instrument Set 7163 2351 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 1927 User Manual English 1 Additional Country Kits TRIGEN SURESHOT Country Kit Australia Cat No 7165 7004 Cat
18. 2 Recon locking mode 30 Verifying targeting accuracy Attach the Radiolucent Drop 7163 1022 to the drill guide to verify targeting accuracy The drop is etched with color coded markings to allow for accurate nail drill guide assembly Insert a 9 0mm Drill Sleeve 7163 1152 and 4 0mm Trocar Drill Sleeve 7163 1026 into the Percutaneous Drill Guide Pass a 4 0mm Long Pilot Drill 7163 1110 through the drill sleeves and nail Insert a 9 0mm Drill Sleeve into the appropriately color coded locking hole on the Radiolucent Drop Pass a 6 4mm Step Drill 7163 1160 through the drill sleeve and nail An incorrectly attached nail will not target With targeting accuracy confirmed remove the drop and any drill sleeves Nail insertion Note Detach set stop before attaching Impactor and inserting nail Orient the drill guide assembly in the AP plane and manually insert the nail into the intramedullary canal as far as possible If necessary attach the Cannulated Impactor Medium 7167 5081 to the drill guide and advance the nail over the guide rod using light blows from the Slotted Hammer 167 4082 As the distal tip of the nail reaches the isthmus of the canal rotate the drill guide to the lateral position Insert the nail to the desired depth Verify fracture reduction as the nail crosses the fracture site paying close attention to rotation length alignment distraction and shortening After nail insertion confirm t
19. 4 Right Rose 7163 5242 7163 5244 7163 5246 7163 5248 7163 5250 Right Rose 7163 5342 7163 5344 7163 5346 7163 5348 7163 5350 Right Rose 7163 5442 7163 5444 7163 5446 7163 5448 7163 5450 Right Rose 7164 5542 7164 5544 Right Rose 7164 5642 7164 5644 Length 42 44 46 48 50 Length 42 44 46 48 50 Length 42 44 46 48 50 Length 42 44 Length 42 44 Neck Angle 130 130 130 130 130 Neck Angle 130 130 130 130 130 Neck Angle 130 130 130 130 130 Neck Angle 130 130 Neck Angle 130 130 TRIGEN TAN Trochanteric Antegrade Nails Set No 7163 1236 5 0mm Internal Captured Screw Gold For 10mm 11 5mm 13mm 14 5mm and 16mm Implants Cat No Length Cat No Length 7164 2225 25mm 7164 2270 70mm 7164 2230 30mm 7164 2275 75mm 7164 2235 35mm 7164 2280 80mm 7164 2240 40mm 7164 2285 85mm 7164 2245 45mm 7164 2290 90mm 7164 2250 50mm 7164 2295 95mm 7164 2255 55mm 7164 2200 100mm 7164 2260 60mm 7164 2205 105mm 7164 2265 65mm 7164 2210 10mm 6 4mm Captured Recon Screw Blue Set No 7163 1341 Cat No Length Cat No Length 7164 2365 65mm 7164 2300 100mm 7164 2370 70mm 7164 2305 105mm 7164 2375 75mm 7164 2310 110mm 7164 2380 80mm 7164 2315 115mm 7164 2385 85mm 7164 2320 120mm 7164 2390 90mm 7164 2325 125mm 7164 2395 95mm TRIGEN Nail Caps Cat No Length Cat No Length 7163 4
20. About The About screen provides more information about the software used Shut down Tap on screen to shut down the system before flipping the power switch Error message An error message will occur if a probe sensor is invalid or broken Distal blocking screws with TRIGEN SURESHOT The white lines displayed on either side of the 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 47 48 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 Interface Connect 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
21. ESHOT Targeter Cat 7169 2801 Drill Bit Short Cat 1169 2810 AO Drill Bit Long Cat No 7169 2811 a B Hexdriver Cat No 7169 2809 Set Stop Cat No 7169 2807 33 34 Detach Cannulated Impactor Medium 7167 5081 from drill guide Reattach Set Stop 7169 2807 and insert Percutaneous TAN FAN Drill Guide Probe 7169 2815 in the nail Adjust probe to nail length Skin incision Use serrated tip of Drill Sleeve to identify 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 I Targeting the locking hole With the appropriate length TRIGEN SURESHOT 4 0mm Drill Bit 7169 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
22. GEN SURESHOT Targeter The 4 7mm 4 0mm step drill will not fit through the drill sleeve Field Accuracy Check fails selected Metal interference within the TRIGEN 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 Verify the correct drill sleeve length is selected from 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 Verify probe is oriented and seated correctly in the notches of the set 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
23. 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 the thumb wheel connection at the end to allow for free movement Preparing the canal Beginning with the 9 0mm End Cutting Reamer Head 7111 8231 and Flexible Reamer Shaft 7111 8200 ream the intramedullary canal sequentially in half millimeter increments to a size 1 1 5mm larger than the selected nail diameter Ensure guide rod position during reaming by inserting the Obturator into the back of the reamer unit during retraction Continue to confirm guide rod position throughout reaming Periodically move the reamer back and forth in the canal to clear debris from the cutting flutes Note The channel reamers will not accommodate reamer heads larger than 12 5mm a The largest Reamer Head that the TRIGEN Base Instrument Tray can hold is 16 0mm Larger sizes are available in the SculptOR Reamer Set 7111 8330 21 22 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
24. SPR c 4 0mm Short Drill Cat No 7163 1117 T handle Cat No 7167 4076 ee lt Medium Hexdriver Cat No 7163 1066 Screwdriver Release Cat 7167 4084 Short Hexdriver Cat No 7163 1068 Mini Connector Cat No 7163 1186 Screw Length Sleeve Cat No 7167 4085 4 0mm AO Short Drill 7163 1123 is interchangeable with 4 0mm Short Drill 7163 1117 41 Distal locking without the TRIGEN SURESHOT system Distal locking is performed in the lateral plane using a free hand technique Reconfirm fracture reduction and align the C Arm over the desired locking hole Obtain a perfect circle image of the locking hole and use a blunt object to approximate the location of the locking hole by dimpling the skin Make a stab incision at the site of screw entry insert the 4 0mm Short Drill 7163 1117 down to bone and drill both cortices Measure for screw length using the Screw Depth Gauge 7163 1189 Alternatively leave the 4 0mm Short Drill in place insert the Screw Length Sleeve 7167 4085 down to bone and read the exposed calibrations off the drill Insert the appropriate length 5 0mm locking screw using either the Medium or Short Hexdriver 7163 1068 and T handle Nail cap insertion Optional Remove the Percutaneous Drill Guide and Radiolucent Drop Attach the selected nail cap to the Medium Hexdriver and T handle and insert into the top of the nail until tight
25. SURESHOT Distal Targeting System Remove any metal objects from the targeting field Verify 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 Verify probe is oriented properly and inserted to the REF notches on probe body Replace probe with a new probe Replace Targeter with a new Targeter and return old one for service 49 Instruments for implant removal Medium Hexdriver Mini Connector Cat No 7163 1066 Cat No 7163 1186 12 5mm Entry Reamer m m Cat 7163 1116 Disposable Nail Extractor Cat No 7163 1320 Cannulated Impactor Medium Cat 7167 5081 Cannulated Impactor Long Cat No 7163 1185 Slotted Hammer Cat No 7167 4082 T handle Cat No 7167 4076 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 Brad Point Drill Tip Threaded Guide Pin Cat No 7167 4130 Cannulated Impactor Long is found in the original TRIGEN Instrument Set 7163 1326 50 Implant removal Optional Open nail extraction technique Remove the nail cap if implanted and all but one of the locking screws using the Medium Hexdriver 163 1066 and T handle Thread the Disposable Nail Extractor 7163 1320 into the Cannulated Impactor Medium or Cannulated Impactor Long 7163 1185 and introduce the extraction assembly into the top of the nail Re
26. TRIGEN Trochanteric and Femoral Antegrade Intramedullary Nails Including TRIGEN SURESHOT Distal Targeting System Indications 2222 2 2 0 0010001 0 000103 2 TRIGEN TAN case examples 4 Design features 5 Implant specifications TAN 6 Design features V 7 Implant specifications FAN 8 Surgical Technique 22 2 42 9 gizneeisi 9 VETS ON FING OMA NE 16 Entry portal acquisition 1 Alternative technique Entry portal 18 Fee ORS TO Oss a a RA 20 Reducer removal eene nnns 20 Implant measurement enne 21 Preparing 21 Unreamed technique 222 020 0 020 0 0200 000000100 nes 22 Nail assembly 24 i uu u a sma 30 Check nail depth cse op RES LI ME 31 Nail anteversion anna 32 Proximal NOG 39 Standard femoral locking 000000000000 39 RECOM 40 TN TR OUR 7 42 cap insertion Optional 42 43 Implant removal
27. aft centerline Recon Lock 12 Anteversion 130 135 TAN 10 11 5 amp 13mm 130 135 TAN Distal Lock M L view Proper Screw Measurement All TRIGEN locking screw measuring devices measure from bottom of head to the last complete thread of screw This is the working length of the screw Thus the screw itself is longer than the measurement and adding length is not necessary Note These views are not to scale and should be used as a pictorial representation only Specifications TRIGEN TAN Nail Material Diameter Lengths Nail Color Left Nail Color Right Cross Section Neck Angle Proximal Diameter driving end Distal Diameter non driving end Smallest Thru Diameter Wall Thickness Guide Bolt Thread Alternative Guide Bolts Removal only Alternative Modes TI6AL4V 10 11 5 amp 13mm 30 50 Lime Rose Round 130 135 13mm 10 11 5 amp 13mm diameter of the nail 5 4mm 2 3mm 10 diameter 3 0mm 11 5 diameter 2 3mm 13 diameter 5 16 24 RT Tibial Retrograde IMSC Revision Standard Femoral Recon Locking Proximal Locking Screw Diameter Major Diameter Minor Diameter Shank Hex Size Alternative Hexdrivers Screw Color Screw Lengths Anteversion Location Proximal Dynamization Slot Proximal Screw Hole Dimensions Degree of Proximal Bend Location of Proximal Bend Standard 5 0mm Recon 6 4mm Standard 5 0mm Recon
28. ail and is center center in the femoral neck and head When using the TRIGEN SURESHOT system to distally lock TAN FAN nails the Anteversion Locking Guide 7169 2816 is used to provisional lock the proximal fragment to the nail Attach Anteversion Locking Guide 7169 2816 to the Percutaneous Drill Guide 7163 1021 Insert 4 0mm Long Drill 7163 1121 and drill deep enough into bone to hold anteversion position Note Anteversion Locking Guide places the drill in the bone just anteriorly to the nail Devices to lock distally M y smith amp nephew TRIGEN SURESHOT Distal Targeting System Trauma Interface Cat No 7169 2802 Power Cord Cat No 6680 0193 Drill Sleeve Long Cat No 7169 2804 umdim Drill Sleeve Short Cat No 7169 2805 lll P ai ss Percutaneous TAN FAN Drill Guide Probe Cat No 7169 2815 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 TRIGEN SUR
29. al 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 and FAN case examples Case Preoperative Postoperative Case 2 Preoperative Postoperative Design features 130 Femoral and 13097 135 Recon screw angles 12 of built in um neck anteversion for optimal proximal screw position Unique five hole proximal locking configuration allows femoral or recon locking modes in one nail Hybrid proximal distal AP Color coded Bow transition 1 5m 2 5m Lime left Rose right distal locking Internal Hex Captured Locking Screws lt Static and dynamic gt configuration using 5 0mm TRIGEN 5 lateral offset for minimally invasive trochanteric entry lt Cannulated round geometry for ease of insertion using reamed or unreamed technique TRIGEN Trochanteric Antegrade TAN specifications 44 From 120 bone shaft centerline Standard Femoral Lock 130 135 TAN From bone sh
30. c 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 TAN FAN Humeral 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 instructions 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 technic
31. e 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 successfully 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 Screw insertion Detach drill seeve from Targeter Introduce Hexdriver with the screw attached 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 trom 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 nea
32. ected SURESHOT Probe SURESHOT Targeter Tip When oriented as shown the connector a should assemble easily Do not force the y 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 25 26 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 7169 2805 that will 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 be used as Tip A different TRIGEN IM nail and or s
33. hat the nail and drill guide are securely connected as hammering can loosen the guide bolt Note If excessive force is required to implant the nail it may be necessary to ream the intramedullary canal additionally 4 0mm AO Long Drill 7163 1121 is interchangeable with 4 0mm Long Pilot Drill 7163 1110 Orient the drill guide assembly in the lateral plane for FAN nail insertion Check depth Proximal Insert the nail until its driving end is at or below the top of the greater trochanter Each gauge on the insertion barrel represents a 10mm depth interval Femoral locking mode Attach the AP Alignment Tower 7163 1025 to the drill guide and slide the back end of the AP Alignment Arm 7163 1015 into the tower Under fluoroscopy the center portion of the alignment arm indicates the path of the 5 0mm locking screw through the trochanteric region 31 32 Recon locking mode Attach the alignment tower to the drop and Slide the back end of the alignment arm into the tower Under fluoroscopy the parallel slots and threaded screw tips of the alignment arm indicate the position of both 6 4mm recon locking screws in the femoral neck and head Distal Verify center center placement of the nail in the distal femoral metaphysis in both the AP and lateral planes Note Remove the 3 0mm Ball Tip Guide Rod Nail anteversion With the C Arm in the lateral position rotate the drill guide until it transects the n
34. ize canbe 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 MAT wey 10 ing is TAM Lf Locking hole accuracy check in the operative field Insert the probe with the assembled set stop through the drill guide and cannulation of the TRIGEN IM nail Tip The Guide Bolt Wrench 7163 1140 may be used as a lever to release the set stop from the drill guide if overtightened 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 medially 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
35. l 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 gt v smith amp nephew SURES HOT ro Distal Targeting System J Trauma Interface Cat No 7169 2802 Power Cord Cat No 6680 0193 TRIGEN SURESHOT Targeter Cat 7169 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 housing 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 Note Verify version 2 0 2 or higher is installed before using Sureshot with TAN FAN Nails To find the software version select MENU gt About Surgical procedure OR preparation Note This procedure will cover only the specific steps of freehand ta
36. ll Tip RUSSELL TAYLOR System 7163 1626 3 0mm x 1000mm Ball Tip 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 52 Catalog information Instruments TRIGEN Base Instrument Set 7167 4012 Instrument Case Cat No Description 7112 9401 Small Outer Case 7112 9402 Lid for Outer Case 7167 4021 TRIGEN Base Tray Instruments Cat No Description 7163 1066 Medium Hexdriver 7163 1068 Short Hexdriver 7163 1116 12 5mm Entry Reamer 7163 1140 Guide Bolt Wrench 7163 1152 9 0mm Drill Sleeve 7163 1161 Multipurpose Driver 7163 1186 Mini Connector 7163 1189 Screw Depth Gauge 7167 4000 Cannulated Awl 7167 4060 Entry Portal Tube 7167 4074 3 2mm T handle Trocar 7167 4075 Honeycomb Instrument Set pictured with additional instruments Tray Qty lea lea lea lea 2 ea lea lea lea lea lea lea lea Cat No 7167 4076 7167 4077 7167 4078 7167 4079 7167 4080 7167 4082 7167 4083 7167 4084 7167 4085 7167 4092 7167 5081 Description T handle Reducer Obturator Ruler Gripper Slotted Hammer 4 0mm Drill Sleeve Screwdriver Release Handle Screw Length Sleeve Entry
37. lot Drill 7163 1110 to power via the Mini Connector 7163 1186 remove the trocar from the drill sleeve assembly and drill both cortices Measure for screw length using either the calibrations on the 4 0mm Long Pilot Drill or by removing the Drill Sleeve Trocar and using the Screw Depth Gauge 7163 1189 Note The 4 0mm Drill Sleeve Trocar must be against the lateral cortex for accurate locking screw length measurement Attach the appropriate length 5 0mm locking screw to the end of the Medium Hexdriver 7163 1066 and insert through the 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 7167 4076 to the hexdriver and tighten the locking screw by hand 4 0mm AO Long Drill 7163 1121 is interchangeable with 4 0mm Long Pilot Drill 7163 1110 40 locking After confirming nail insertion depth and femoral neck anteversion make two small incisions at the site of screw entry Insert a 9 0mm Drill Sleeve 4 0mm Drill Sleeve Trocar and 4 0mm Trocar into the inferior most recon locking hole on the Radiolucent Drop 163 1022 and down to bone Repeat the process for the superior locking hole Remove the 4 0mm Trocar from the inferior trocar sleeve assembly Attach the 4 0mm Long Pilot Drill to power via the Mini Connector and drill to the desired depth in the femoral neck and head Leave the 4 0mm drill in place and repeat the pr
38. medullary canal Rotate the C Arm to ensure optimal AP and lateral visualization of the entire femur Note If using a radiolucent table a distraction device may be helpful in reducing the fracture 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 In the event of improper use Smith amp Nephew accepts 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
39. 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 within the TRIGEN SURESHOT electromagnetic field TRIGEN SURESHOT Targeter and probe not within range of each other Remove any metal objects from the targeting field Move the TRIGEN SURESHOT Targeter closer to the sensor 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 option and use the long drill bit Red and Green targeting circles Incorrect drill sleeve length representing the drill sleeve appear incorrect Targeting missed the intended hole Drill sleeve cannot be removed from TRI
40. move the final locking screw s and extract the nail with a back slapping motion using the Slotted Hammer Percutaneous nail extraction technique This technique assumes the absence of a nail cap Attach a 3 2mm x 343mm Brad Point Drill Tip Threaded Guide Pin to power via the Mini Connector and insert into the top of the nail under fluoroscopy This may also be performed manually Attach the 12 5mm Entry Reamer 7163 1116 to power Make a one inch incision around the guide pin and advance the entry reamer over the guide pin and into the top of the nail to remove bony in growth Nail extraction follows the previously described technique Note The tip of the entry reamer is straight for approximately one inch before flaring out It is this portion of the entry reamer that enters the top of the nail Cannulated Impactor Long is found in the original TRIGEN Instrument Set 7163 1326 51 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 Ba
41. ntry point for the Trochanteric 5 Antegrade TAN is located lateral to the tip gt of the greater trochanter approximately 5 from 7 if M the anatomical axis in the AP and in line with 7 intramedullary the lateral view lt GE E S m m mm m 2 E The entry point for the is in line with the center of the intramedullary canal in both the AP and the lateral views The entry point is slightly posterior in the top view shown although this varies with patient anatomy This surgical technique is written from the Trochanteric Antegrade Nail TAN perspective The Femoral Antegrade Nail FAN technique changes with respect to nail entry point and insertion technique Entry acquisition Insert the Entry Portal Instrumentation through the incision down to bone Attach a 3 2mm x 343mm Brad Point Drill Tip Threaded Guide Pin 167 4130 to power via the Mini Connector 7163 1186 and insert 2 3cm into the trochanteric region Avoid over insertion of the guide pin as this can establish a false trajectory and lead to fracture malalignment Confirm guide pin placement in the AP and lateral planes Note In the instance of suboptimal guide pin placement rotate the Honeycomb within the Entry Portal Tube to the desired location and insert another 3 2mm guide pin Following guide pin placement remove the Honeycomb from the Entry Portal Tube al
42. ocess for the superior trocar sleeve assembly Measure for screw length using the calibrations on the 4 0mm Long Pilot Drill Note The 4 0mm Drill Sleeve Trocar must be against the lateral cortex for accurate locking screw measurement Note As the 9 0mm Drill Sleeve is inserted through the Radiolucent Drop rotating the Sleeve back and forth will allow for easier insertion Remove the 4 0mm drill and drill sleeve trocar from the inferior 9 0mm Drill Sleeve Attach the 6 4mm Step Drill 7163 1035 to power and drill to the depth measured for the 6 4mm recon locking screw The calibration on the drill will be flush with the back of the drill sleeve Leave the step drill in place and repeat the process for the superior locking screw Note It is recommended to monitor all drilling under fluoroscopy to avoid penetration of the acetabulum Attach the appropriate length 6 4mm recon locking screw to the Medium Hexdriver and T handle Remove the inferior 6 4mm Step Drill and insert the locking screw through the 9 0mm Drill Sleeve Do not tighten definitively Repeat the process for the superior Recon locking screw using the Long Hexdriver 7163 1070 and T handle Release any traction and tighten both locking screws definitively Not included in the TRIGEN Base Instrument Set 7167 4012 Instruments for distal locking without the use of the TRIGEN SURESHOT system Screw Depth Gauge Cat No 7163 1189 CELO SPER R
43. olor Screw Lengths Anteversion Location Proximal Dynamization Slot Proximal Screw Hole Dimensions Degree of Proximal Bend Location of Proximal Bend Standard 5 0mm Recon 6 4mm Standard 5 0mm Recon 6 4mm Standard 4 3mm Recon 4 7mm Standard N A Recon 6 3mm 4 7mm RT Femoral amp Recon 7 0mm Cannulated Screw PERI LOC Locking Screw Guide Standard Lock Gold Recon Lock Blue Standard 25 110mm Recon 65 125mm Recon Lock 12 Degrees 21 33 amp 47mm No Standard 5 3mm Recon 6 4mm N A N A Distal Locking Screw Diameter Major Diameter Minor Diameter core Screw Color Screw Lengths Location Orientation Dynamization Slot Distal Screw Hole Dimensions AP Bow Location of Distal Bend Dynamization Slot Location 5 0mm 5 0mm 4 3mm Gold 25 110mm 15 20 amp 40mm L M Yes 5 3mm Hybrid Bow Proximal 1 5 meters Distal 2 5 meters 100mm Distal Surgical Technique Patient positioning Place the patient in the supine or lateral decubitus position on a fracture table The foot of the affected limb is placed in a foot holder or a pin is inserted through the calcaneus for traction purposes The unaffected limb is extended below and away from the affected limb or flexed and placed in a leg holder Check the affected limb for length and rotation by comparison to the unaffected limb Abduct the torso 10 15 to allow clear access to the intra
44. ong with any additionally inserted guide pins Insert the 12 5mm Entry Reamer 7163 1116 into the 14mm Channel Reamer 7163 1039 until it clicks and attach to power Advance the assembly through the Entry Portal Instrumentation 2 3cm into the trochanteric region Evaluate reamer position before proceeding Adjust the trajectory of the reamer assembly if desired and advance to the positive stop on the Entry Portal Tube The channel reamer will stop just below the level of the lesser trochanter If the Entry Portal Instrumentation is not used the channel reamer must still be advanced to the same point Confirm the reamer assembly s final position in both the AP and lateral planes Detach and remove the 12 5mm Entry Reamer from the 14mm Channel Reamer Note The channel reamer and Entry Portal Instrumentation will serve as a soft tissue protector Alternative technique Entry portal Attach the T handle 7167 4076 to the Cannulated Awl 7167 4000 and insert the 3 2mm T handle Trocar 7167 4074 into the back of the assembly Introduce the awl into the proximal femur at the designated entry point until it is below the level of the lesser trochanter Remove the 3 2mm Trocar and pass a 3 0mm Ball Tip Guide Rod 7163 1626 into the back of the T handle Remove the awl from the proximal femur The region of the proximal femur extending to the lesser trochanter must be enlarged to 14mm in order to accommodate the proximal geome
45. r 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 Instruments for proximal locking 4 Trocar Drill Sleeve Cat No 7163 1026 4 0mm Trocar Cat No 7163 1191 Cat No 7163 1071 9 0mm Drill Sleeve Percutaneous Drill Guide Cat No 7163 1152 Screw Depth Gauge Cat No 7163 1189 Radiolucent Drop Cat No 7163 1022 T handle Cat No 7167 4076 Screwdriver Release Medium Hexdriver Cat No 7167 4084 Cat No 7163 1066 SSE lt 6c aaa Long Hexdriver M Cat No 7163 1070 7163 1186 4 0mm Long Pilot Drill Cat No 7163 1110 6 4mm Tap Cat No 7163 1036 Not included in the TRIGEN Base Instrument Set 7167 4012 4 0mm AO Long Drill 7163 1121 is interchangeable with 4 0mm Long Pilot Drill 7163 1110 38 Note Make sure to remove probe before proximal locking Proximal locking Standard femoral locking Slide the 4 0mm Trocar 7163 1191 into the 4 0mm Drill Sleeve Trocar 7163 1026 and insert into a 9 0mm Drill Sleeve 7163 1152 Make a small incision at the site of screw entry and insert the trocar sleeve assembly through the hole on the drill guide and down to bone Attach the 4 0mm Long Pi
46. rgeting 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 Tip If the Trauma Interface does not power on place the Trauma Interface 7169 2802 in the make sure the switch is in the position desired non sterile location and turn on the Note No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table contained in Smith amp Nephew document 7118 1927 power switch Pressing the power button will bring up the start up screen Meum A arp L 7 Note Targeter body have contact with TRIGEN SURESHOT Targeter connection the patient and must remain in the sterile field at When the display prompts for tool connections all times Only the cable and connector may be connect the TRIGEN SURESHOT Targeter removed from the sterile field 7169 2801 to the Targeter port on the Note This step needs to be performed at least Trauma Interface 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
47. try of a 10mm 11 5mm or 13mm TAN FAN nail If inserting a 14 5mm or 16mm the proximal femur must be reamed to 17 5mm Note Intramedullary reamers should be used to prepare the proximal femur if the 14mm Channel Reamer is not used The entry point for the Cannulated Awl will differ depending on whether a TAN or FAN is being implanted The largest Reamer Head that the TRIGEN Base Instrument Tray can hold is 16mm Larger sizes are available in the SculptOR Reamer System 7111 8330 Instruments for fracture reduction intramedullary reaming Entry Portal Tube Cat No 7167 4060 Entry Portal Handle Cat No 7167 4092 Ruler Cat No 7167 4079 eo 14mm Channel Reamer Gripper Cat No 7163 1039 Cat No 7167 4080 Obturator Cat No 7167 4078 T handle Reamer Heads Cat No 7167 4076 Cat No 7111 8231 to 7111 8256 Reamer Shaft Cat No 7111 8200 Reducer Cat No 7167 4077 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 The largest Reamer Head that the TRIGEN Base Instrument Tray can hold is 16 0mm Larger sizes are available in the SculptOR Reamer Set 7111 8330 20 Fracture reduction Insert the back end of the 3 0mm Ball Tip Guide Rod 7163 1626 into the front end of the Gripper 7167 4080 and gently close the trigger grip Connect the Reducer and Reducer Connector 7167 4077 so that the words Slot Orientation are in line with the opening at the tip Complete the Red
48. ucer assembly by connecting it to the T handle 7167 4076 Introduce the Reducer into the intramedullary canal through the channel reamer and Entry Portal Instrumentation Care should be taken to maintain fracture reduction Pass the ball tip guide rod through the back of the T handle and insert to the desired depth using the Reducer s curved tip to avoid any areas of comminution The guide rod should be center center in the AP and lateral views Reducer removal Once the guide rod is in position detach the Gripper and remove the Reducer from the intramedullary canal Slide the Obturator 7167 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 position in the distal femur Advance the Ruler 7167 4079 over the guide rod through the Channel Reamer 7163 1039 and Entry Portal Instrumentation to the desired depth The bottom of the Ruler s metal tip denotes the driving end of the nail Note Fractures should be treated with the longest nail possible in order to reduce the likelihood of stress risers Confirm guide rod position in the window at the proximal end of the Ruler as shown in order to ensure accurate implant measurement Push down on the top of the Ruler until contact is made with the guide rod Implant length is read from the exposed calibrations near the thumbwheel on the Ruler
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