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1. 7165 3034 Contained in the standard implant set 44 Length 18cm 20cm 22cm 24cm 26cm 28cm 30cm 32cm 34cm Cat No 7165 3036 7165 3038 7165 3040 7165 3042 7165 3044 7165 3046 7165 3048 7165 3050 Length 36cm 38cm 40cm 42cm 44cm 46cm 48cm 50cm 5 0mm Gold Screw Catalog information TRIGEN META NAIL Implants TRIGEN META NAIL 11 5mm Retrograde Femoral Set No 7165 1001 Cat No 7165 3218 7165 3220 7165 3222 7165 3224 7165 3226 7165 3228 7165 3230 7165 3232 7165 3234 TRIGEN META NAIL 13mm Retrograde Femoral Length Cat No 18cm 7165 3236 20cm 7165 3238 22cm 7165 3240 24cm 7165 3242 26cm 7165 3244 28cm 7165 3246 30cm 7165 3248 32cm 7165 3250 34cm Set No 7165 1002 Cat No Length Cat No 7165 3418 18cm 7165 3436 7165 3420 20cm 7165 3438 7165 3422 22cm 7165 3440 7165 3424 24cm 7165 3442 7165 3426 26cm 7165 3444 7165 3428 28cm 7165 3446 7165 3430 30cm 7165 3448 7165 3432 32cm 7165 3450 7165 3434 34cm Nail Cap Set Screw Cat No 7165 6000 TRIGEN Nail Caps Cat No 7163 4000 7163 4005 7163 4010 Length Cat No Length Omm 7163 4015 15mm 5mm 7163 4020 20mm 10mm Contained in the standard implant set Length 36cm 38cm 40cm 42cm 44cm 46cm 48cm 50cm Length 36cm 38cm 40cm 42cm 44cm 46cm 48cm 50cm 45 Catalog Information TRIGEN META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set No 716
2. Note The Blocking Screw Alignment Pins 7165 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 alignment Tighten the device to the Awl and insert the appropriate Blocking Screw Cartridge 7165 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 0 mm 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 neurovascular structures located posterior to the distal femur 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 36 Following implantation of the distal blocking screw and fracture reduction pass the 11 0mm T handle Awl into the proximal fragment Reposition either the Blocking Screw Cartridge or the Awl as necessary and follow the previ
3. 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 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
4. 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 48 A de 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 49 Instruments used if you 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 50 Catalog information TRIGEN META NAIL Instruments Mini Connector fee Cat No 7163 1186 Screw Depth Gauge
5. any part of the instructions is unclear please contact your local Smith amp Nephew 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 mal function 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 Refer to the SURESHOT User Manual 7118 1540 for details about the SURESHOT Distal Targeting System ML view Note These views are not to scale and should be used as a pictorial representation only Set does not include all sizes Additional sizes may be special order only 4 Non driving end of nail Top view of nail Driving end of nail Specifications TRIGEN META NAIL Retrograde Femoral Material Diameter Lengths Nail Color Cross Section Distal Diameter driving end Proximal Diameter non driving end Smallest Thru Diameter Wall Thickness Guide Bolt Thread Screw Diameter Screw Color Major Diameter Minor Diameter core Screw Le
6. drop down menu OR by pressing the implant tab located in the lower left corner of the navigation screen 21 Surgical procedure after IM Nail Assembly to the Drill Guide Drill sleeve attachment Tightly secure the selected drill sleeve to the Targeter Note The short long and long combo drill sleeves 7169 2805 7169 2804 and 7169 1166 can be loosened from the Targeter using the slot in the TRIGEN Hammer 7167 4082 22 Nail insertion Detach wing 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 7167 4082 to the desired depth Additional reaming of the intramedullary canal may be necessary if excessive force is required to insert the nail Verify fracture reduction as the nail crosses the fracture 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 23 Check nail depth Distal In the AP and lateral views confirm nail position within the distal femur The notch at the nail drill guide junction will be visible in the lateral Each gauge on the insertion barrel represents a 10mm depth interval Proximal In the AP view confirm that the nail has been inserted to the de
7. only with META NAIL Stan dard Drill Guide 7169 2814 Set the probe to the length of the TRIGEN IM Nail 20 SURESHOT Probe META connected Confirm that the tool connection has been verified Note When oriented as shown the connector should assemble easily Do not force the connector into the port Simply try rotating the connector until the keys are oriented in the 12 o clock position 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 Note 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 Surgical procedure atter IM Nail Assembly to the Drill Guide Drill sleeve selection Select the length of the drill sleeve 7169 2804 7169 2805 or 7169 1165 and 7169 1166 that will be used A different sleeve can be selected at any time during the procedure by choosing the drill sleeve option from the drop down menu OR by pressing the drill sleeve tab located in the lower right corner of the navigation screen Implant selection screen Select the TRIGEN IM Nail and size that will be used META NAIL Note A different TRIGEN IM Nail and or size can be selected at any time during the procedure by choosing the Implant option from the
8. senenennenzznnenznzznnenzznznzznzznnzznzznznnnrznznnznnznz za 37 Blocking screw insertion with reducer ss nennnennenenne nn ren ent 38 Stability blocking screw insertion ss eennnnnennenzznznnnnznzznznnenzznznnnnznzznznnz nt za 39 Nail Cap iNSErtON assi nee 40 Nail extraction Optional Standard techNigUE assi ed nun oiee AEN EEEE E a ETENE 42 Perc tanecus TOC I GUNS essen Aid ra 42 G ide rod jamming CC NN sssini ionin aea EEEE 43 Catalog information 22 nn 44 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 Retrograde Femoral Nail is indicated for fractures of the femur including stable and unstable distal metaphyseal fractures diaphyseal fractures intraarticular fractures periprosthetic fractures nonunions malunions and for the prophylactic nailing of impending pathological fractures 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
9. 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 Critical Verify there are no other metal objects including metal triangles in the field Metal interference will cause the system to be inaccurate 2 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 A note will appear on screen warning of compromised targeting field if magnetic metal is close If it is in the field image disappears Drill Depth Measurement Refer to User Manual Page 16 and 17 for drill depth measurements 28 Screw insertion Using the TRIGEN SURESHOT Hexdriver 7169 2809 the screw may be inserted using the Targeter WARNING The standard TRIGEN Hexdrivers are made from magnetic stainless steel that will cause interference with the system and cannot be used Using the Combo Drill Sleeve TRIGEN SURESH
10. 5 4001 Blocking Screw Device Cat No 7165 4515 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 Retrograde Femoral Blocking Screw Attachment Cat No 7165 4508 Blocking Screw Instrument Case Cat No 7165 4552 Blocking Screw Instrument Lid Cat No 7165 4553 46 Catalog information TRIGEN META NAIL Instruments TRIGEN META NAIL Blocking Screw Instruments Set No 7165 4002 META NAIL Anterior Drop Cat No 7165 4501 META NAIL Drill Guide Cat No 7165 4502 META NAIL Extension Drill Guide Cat No 7165 4503 Extension Guide Bolt 23mm pe lii Cat No 7165 4505 Guide Bolt Long 51mm oe 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 jw Cat No 7165 4554 pl 4 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
11. OT Inner Drill Sleeve Long Cat No 7169 1165 4 TRIGEN SURESHOT Outer Screw Sleeve Long Cat No 7169 1166 1 While holding the Targeter to bone remove the SURESHOT Inner Drill Sleeve Long 7169 1165 from the SURESHOT Outer Screw Sleeve Long 7169 1166 2 Use the TRIGEN SURESHOT Hexdriver 7169 2809 to insert the appropriate length screw through the SURESHOT Outer Screw Sleeve Long 3 When screw insertion is complete remove the probe trom the IM nail 29 Instruments for standard dynamic and compression locking Nail Cap Set Screw Cat No 7165 6000 Screw Length Sleeve Cat No 7167 4085 META NAIL Anterior Drop Cat No 7165 4501 Medium Hexdriver Cat No 7163 1066 te ee Mini Connector Cat No 7163 1186 4 0mm Drill Sleeve Cat No 7167 4083 9 0mm Drill Sleeve Cat No 7163 1152 Screwdriver Release 4 0mm Long Pilot Drill Cat No 7167 4084 Cat No 7163 1110 Universal META NAIL Compression Driver Cat No 7165 4528 ee ei oH m i d z ur 4 0mm Short Drill iy Cat No 7163 1117 T handle Cat No 7167 4076 BEER Screw Depth Gauge Cat No 7163 1189 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 30 Locking screw measurement There are three methods 1 Gold 9 0mm Drill Sleeve silver 4 0
12. TRIGEN META NAIL Retrograde Femoral Nail System Including TRIGEN SURESHOT Distal Targeting Svstem WGC AU OWNS a ee 2 Implant 21072101 005 1 07 L I 4 Surgical technique Pallet POSINO MI ernennen ee ected aneeteeaane ieee 5 INCISION and entry point 2 eee cece cesccesccscessececcssscsescseceseseseseseesscesseseesesaeents 10 Entry point Entry portal acquisition ss seen enza rna 11 A O E A 12 Alternative technique Entry portal ss see snnennennnnnnnzznnznnzzznnennzznnnznnzznnzn tan znn nanna 12 Facer du iO i re pe a e er 14 PUI ST TEN OA ee ee een 15 Implant measurement ceucseaseeaseenseenneennennnnnnnennnnnnennnnennnennennnnennnennnnnnennnennnennnnnnnnn 15 NTEINEA TECHN I ee en ee 16 Reamed JA CETO a a 0 TA TJ 17 VAS SOTA EEE WEERENIREEEI NNORNESWENEENCHEEETENINERPEUEENINEEENIENEREE 19 NAIA OO e E ee 23 Check nail depth oc cecccccc cc ccseccsscesscesecesecesecesecssecssecsssessecsssesssesssesesesesestesseseseees 24 Locking screw measurement e ee 3 Locking screw insertion 0 0sssssesmennnnnnzenzenznzznzannzznznnnzznzznrinintinzzziztirarzzzzzznzzazzazii 3 DIST AAC CNS escape 32 PrOXIMaL NOI MS ee ee eee ate sense A 33 Blocking screw technique INCISION and entry point 2 ee ccc ccc cesccesccscessecesccsesesesesseesesesesestesesesteseesseeasenes 35 Enirv DORT AC IS DON nee ee 35 AP blocking screw insertion une 36 ML blocking screw insertion ss se
13. _ Z Cat No 7163 1189 Screw Driver Release Handle Cat No 7163 1208 Cannulated Impactor Long Cat No 7163 1185 Flexible Reamer Shaft EEE 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 4 0mm Short Drill nn a 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 Disposable Compression Driver CN ne Cat No 7165 4517 Disposable Nail Extractor f Cat No 7163 1320 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 xx 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 Catalog information TRIGEN SURESHOT Instruments TRIGEN SURESHOT Targeting Interface Cat No 7165 7000 Cat No Device Case Qtv 7169 2802 Trauma Interface 1 TRIGEN SURESHOT Targeting Instrument Set Set No 7165 7001 Cat No Description Trav Qtv 7169 2801 Targeter 7169 2804 Drill Sleeve Long 7169 2805 Drill Sleeve Short 7169 2806 META Set Stop 7169 2807 TAN Set Stop 7169 2808 Field Accuracy Gauge 7169 2809 Hexdriver 7169 2816 TAN Anteversion Loc
14. andle Cat No 7167 4092 3 2mm T handle Trocar Cat No 7167 4074 Cannulated Awl Cat No 7167 4000 Incision and entry point Assemble the Honeycomb 7167 4075 Entry Portal Handle 7167 4092 and Entry Portal Tube 7167 4060 The pieces will lock in place securely at either 0 or 180 A 3 4cm midline incision is made followed by a medial parapatellar capsular incision to expose the intercondylar notch Gently retract the patellar tendon laterally The entry point is located within the intercondylar notch just anterior and lateral to the femoral attachment of the posterior cruciate ligament en Entry portal acquisition Attach a 3 2mm Tip Threaded Guide Wire 7163 1690 to the drill via the Mini Connector 7163 1186 and insert 6 8cm into the distal femoral metaphysis The Entry Portal Instrumentation serves as a soft tissue protector The guide wire should be in line with the femoral axis in the AP view and anterior to Blumensaat s Line in the lateral view In the instance of suboptimal wire placement rotate the Honeycomb within the Entry Tube to the desired location and insert another 3 2mm Tip Threaded Guide Wire Blumensaat s Line N 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 the Guide Wire t
15. d to determine nail size The appropriate diameter implant will provide translational fill within the isthmus of the intramedullary canal Generally selection of a nail at least 1 1 5mm less than the narrowest canal measurement on the lateral radiograph assists in avoiding implant incarceration during insertion 16 Jojo jojo jojo jo jojo A P VIEW i Drill Guide i 12mm Top of Nail 10mm 20mm 30mm 40mm 50mm LATERAL VIEW m a 30mm 35mm WW V_ 40mm 45mm Ua 50mm mm a 60mm 65mm I a 70mm 75mm N a 80mm 85mm iV Uy 90mm 95mm sy ur 100mm 105mm V_ 110mm 5 0mm Gold Screw l l Size Omm Set Screw Nail Cap l Size Omm Nail Cap l 5mm a N oo 15mm us LI me 20mm Nail Cap Distal Diameter TRIGEN META NAIL Femoral Retrograde Nail Radiographic Template Cat No 7118 0811 Reamed technique Radiographic templating and intraoperative measurement will determine nail size Beginning with the 9 0mm Front 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 size Ensure guide rod placement during reaming by inserting the Obturator into the back of the Reamer unit during retraction Continue to confirm Guide Rod placement i
16. e 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 Out Available sterile packed For nail removal only do not use for nail insertion Located in RUSSELL TAYLOR Extraction Kit Set 7508 available through Loaners 43 Catalog information TRIGEN META NAIL Implants 5 0mm Internal Captured Screws Gold Cat No 7164 2225 7164 2230 7164 2235 7164 2240 7164 2245 7164 2250 7164 2255 7164 2260 7164 2265 7164 2270 7164 2275 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 Cat No 7164 2280 7164 2285 7164 2290 7164 2295 7164 2200 7164 2205 7164 2210 Length 80mm 85mm 90mm 95mm 100mm 105mm 110mm TRIGEN META NAIL 10mm Retrograde Femoral Set No 7165 1000 Cat No 7165 3018 7165 3020 7165 3022 7165 3024 7165 3026 7165 3028 7165 3030 7165 3032
17. er Manual Spanish 1 53 TRIGEN SURESHOT Country Kit Italy Cat No 7165 7009 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 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 54 Notes 55 Notes 56 Smith amp Nephew Inc 7135 Goodlett Farms Parkway www smith nephew com Cordova TN 38016 USA Telephone 1 901 396 2121 Information 1 800 821 5700 Orders Inquiries 1 800 238 7538 2014 Smith amp Nephew Inc All rights reserved Trademark of Smith amp Nephew Certain marks Reg US Pat amp TM Off 01362 VI 71181613 REVB 01 14
18. fe 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 WARNING The maximum temperature of the Targeter body can reach 47 Celsius at ambient room temperatures above 30 C The Targeter body should not remain in constant contact with a patient s exposed skin for more than one minute Surgical procedure OR preparation Trauma Interface setup Atter the sterile areas have been established place the Trauma Interface 7169 2802 in the desired non sterile location and turn on the power switch CAUTION No other electrical devices should be placed near the Trauma Interface See the Guidance and Manufacturer s Declaration Separation Distances table at the end of this document Note If the Trauma Interface does not power on make sure the switch is in the on position Note The means for mains disconnection of power to the Trauma Interface is the appliance inlet located below the power switch The Trauma Interface should not be positioned such that it is difficult to reach this location TRIGEN SURESHOT Targeter connection When t
19. he display prompts for tool connections connect the TRIGEN SURESHOT Targeter 7169 2801 to the Targeter port on the Trauma Interface SURESHOT Probe SURESHOT Targetor ma faqrid mat found Surgical procedure OR preparation The SURESHOT Targeter will change color to orange upon successful connection to the Trauma Interface CAUTION 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 CAUTION Connect the Targeter at least 10 minutes prior to targeting in order to ensure proper accuracy Note 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 Note 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 Instruments for opening the distal femur 3 2mm Tip Threaded Guide Wire Cat No 7163 1690 12 5mm Entry Reamer Cat No 7163 1116 en Mini Connector Cat No 7163 1186 T handle Cat No 7167 4076 Honeycomb Cat No 7167 4075 Entry Portal Tube Cat No 7167 4060 Entry Portal H
20. hrough the Entry Tube to a depth of 6 8cm Check position via radiographic imaging and then remove the 12 5mm Entry Reamer and 3 2mm Tip Threaded Guide Wire Alternative technique Entry portal Attach the T handle 7167 4076 to the Cannulated Awl 7167 4000 and insert into the distal femur to a depth of 6 8cm 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 with T handle 3 2mm T handle Trocar Instruments for fracture reduction and reaming Epe Entry Portal Tube Cat No 7167 4060 Entry Portal Handle Cat No 7167 4092 Gripper Cat No 7163 4080 Ruler Cat No 7167 4079 T handle Cat No 7167 4076 Reamer Heads Cat No 7111 8231 8242 Obturator x Cat No 7167 4078 Reamer Shaft Cat No 7111 8200 o Soo ae Reducer Cat No 7167 4077 m 3 0mm Ball Tip Guide Rod Cat No 7163 1626 13 Fracture reduction Insert the back end of the 3 0mm Ball Tip Guide Rod 7163 1626 into the front 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 assembly by connecting it to the T handle 7167 4076 Note If blocking screws are desired at this point in the p
21. ice Cat No 7165 4515 un 4 0mm Drill Sleeve Mini Connector Cat No 7163 1156 Cat No 7163 1186 T handle Cat No 7167 4076 9 0mm Drill Sleeve Cat No 7163 1152 Medium Hexdriver Cat No 7163 1066 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 34 Blocking screw technique Incision and entry point A 3 4cm midline incision is made followed by a medial parapatellar capsular incision to expose the intercondylar notch Gently retract the patellar tendon laterally The entry point is located within the intercondylar notch just anterior and lateral to the femoral attachment of the posterior cruciate ligament Entry portal acquisition Insert the 11 0mm T handle Awl 7165 4522 F manually to a depth just distal to the fracture Pa 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 femur Correct Awl trajectory in the distal fragment must be established prior to alignment with the anatomic axis of the proximal fragment This will ensure accurate fracture reduction when the nail is inserted AP blocking screw insertion In order to prevent varus or valgus malalignment _ of the distal 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
22. ide and can be seen in the lateral view as a means for determining distal insertion depth Note Do not use the META NAIL Extension Drill Guide to insert the Retrograde Femoral Nail as the Insertion Barrel is too short to allow for adequate countersinking of the nail It is recommended to use the standard drill guide and Long Guide Bolt due to the longer Insertion Barrel 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 7163 1110 through the assembly An incorrectly attached nail will not target Refer to SURESHOT User Manual for the Field Accuracy check instructions 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 19 Surgical procedure atter IM Nail Assembly to the Drill Guide Probe connection Connect the probe to either of the probe sensor ports on the Trauma Interface Probe selection and assembly Assemble the appropriate probe and set the stop for the the TRIGEN IM Nail and Drill Guide that will be used CAUTION Proper orientation of the probe to the set stop as shown is required Failure to do so may result in inaccurate targeting TRIGEN SURESHOT META NAIL Standard Drill Guide Probe 7169 2814 For META NAIL notches should face anteriorly Red probe Use
23. king Guide 7169 2830 Targeting Instrument Tray 7169 2831 Targeting Instrument Tray Lid Other TRIGEN SURESHOT Instruments Cat No Description Qty 7169 1165 Inner Drill Sleeve Long 1 7169 1166 Outer Screw Sleeve Long 1 Set No 7165 7002 Cat No Description Qty 7169 2810 AO Drill Bit Short 2 7169 2811 AO Drill Bit Long 1 Additional Disposable Ber Cat No Description MW 7169 2814 META NAIL Standard Drill Guide Probe used with TRIGEN META NAIL Instrument Set 7165 4002 52 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 No Description Qty 6680 0303 Power Cord 250 Volt 10 Amp 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 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 Amp 1 Continental Europe 7118 1539 Us
24. l 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 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 32 Proximal locking without the use of TRIGEN SURESHOT Proximal locking is performed in the AP plane using a free hand technique Confirm 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 insert the 4 0mm Long Pilot Drill and drill both cortices Measure for screw length using the Screw Depth Gauge Alternatively leave the 4 0mm Long Pilot Drill in place insert the Long Screw Length Sleeve down to bone and read the exposed calibrations off the drill Insert the appropriate length screw using the Medium Hexdriver T handle assembly 33 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 Blocking Screw Alignment Pin Cat No 7165 4523 Retrograde Femoral Blocking Screw Attachment Cat No 7165 4508 11 0mm T handle EEE Awl 4 0mm Long Pilot Drill Blocking Screw al No 7109 4522 Cot No 7163 1110 Dev
25. ment volume 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 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 26 Pui Tareas hack fully bo mansune depth 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 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
26. mm Drill Sleeve and 4 0mm Long Pilot Drill 2 Screw Depth Gauge 7163 1189 3 Long Screw Length Sleeve 7165 4520 and 4 0mm Long Pilot Drill Locking screw insertion Distal locking options include three statically locked threaded holes that are targeted through the orange and green color coded holes on the Anterior Drop Proximal locking options include two statically locked nonthreaded AP holes Gold 5 0mm locking screws are compatible with 10 11 5 and 13mm diameter nails Note The 4 0mm Short Step Drill 7164 1123 may be used to drill for a gold 5 0mm locking screw in the instance of hard cortical bone The 4 7 4 0mm width transition facilitates easier screw insertion without compromising purchase 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 3 Note Make sure to remove probe before proximal locking Distal locking without the use of TRIGEN SURESHOT Make a small incision at the site of screw entrv and insert the gold 9 0mm Drill Sleeve and silver 4 0mm Drill Sleeve through the desired 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 Dril
27. n the proximal femur 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 Guide Bolt Long Cat No 7165 4506 Cannulated Impactor Short Cat No 7165 4554 T handle Cat No 7167 4076 META NAIL Standard Drill Guide Probe Cat No 7169 2814 Guide Bolt Wrench Cat No 7163 1140 META NAIL Anterior Drop Cat No 7165 4501 9 0mm Drill Sleeve Cat No 7163 1152 4 0mm Drill Sleeve Cat No 7167 4083 PER on 4 0mm Long Pilot Drill Cat No 7163 1110 Cannulated Impactor Medium Cat No 7167 5081 Slotted Hammer Cat No 7167 4082 META Set Stop Cat No 7169 2806 4 0mm Long Pilot Drill 7163 1110 is interchangeable with 4 0mm AO Long Drill 7163 1121 18 a N 98 Nail assemblv 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 7163 1140 and T handle The nail is correctly aligned when The line on the insertion barrel matches the line on the back of the nail The A on the nail matches the A on the insertion barrel The apex of the nail s AP Bow and the drill guide itself are oriented anterior The bevel on the front of the nail marks the connection to the drill gu
28. nents should be addressed with interfragmentary screw fixation prior to nail insertion Care should be taken to place the screws in the anterior and posterior aspect of the distal femur and safely out of the nail s intended path Note Cannulated screw guide wires allow for confirmation of definitive screw placement prior to fracture fixation and nail insertion Use a bolster or radiolucent triangle to maintain limb position Rotate the C Arm to ensure optimal AP and lateral visualization of the entire femur 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 Refer to the SURESHOT User Manual 7118 1540 for all warnings cautions maintenance cleaning and sterilization instructions Devices for system set up U smith amp nephew TRIGEN SURESHOT Distal Targeting Syslern TRIGEN SURESHOT Targeter gt Cat No 7169 2801 Trauma Interface Note The Targeter will be operated within the Cat No 7169 2802 Sterile tield and may have contact with the skin Power Cord of the patient The drill sleeve inserts will be used Cat No 6680 0193 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 sa
29. ngths Hex Size Alternative Hexdrivers Alternative Modes Distal Locking Driving End Static Lock Locations Orientations Static Locking Hole Dimensions Static Lock Locations Orientations Static Locking Hole Dimensions Proximal Screw Hole Diameter AP Bow Radius AP Bow Location TI6AL4V 10 11 5 amp 13mm 18 50cm Gold Round 12mm 10 11 5 dia 13mm 13 dia 10 11 5 amp 13mm 5 0mm 2 3mm 10 dia 3 0mm 11 5 dia 2 3mm 13 dia 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 15mm ML Threaded Can be locked with META NAIL Cap 30mm 25 Threaded w bushing 40mm 25 Threaded w bushing Threaded 4 5mm minor dia Threaded 5 3mm major dia 15mm AP 35mm AP 5 3mm 5 3mm 2M Starts 100mm from Driving End Surgical technique Patient positioning Position the patient supine on a radiolucent table Flex the affected limb approximately 45 over a posterior support to assist with fracture reduction Check for length and rotation by comparison to the unaffected limb Rotate the C Arm to ensure optimal AP and lateral visualization of the entire femur The C Arm should be able to freely access the femur up to and including the intertrochanteric area A distraction device may also be applied to obtain and or maintain traction Intraarticular fracture compo
30. on 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 With the nail inserted attach the Retrograde Femoral Blocking Screw Attachment 7165 4508 to the Anterior Drop matching the orange shape found on the Blocking Screw Attachment to the corresponding one on the 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 superior oblique distal locking screw has been inserted 39 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 and nail cap Set screw insertion optional Remove the drill guide Anterior Drop assembly Attach the selected Nail Cap or Nail Cap Set Screw to the Medium Hexdriver T handle assembly and insert into the end of the nail until tight Note The TRIGEN Nail Cap does not engage with the most distal locking screws to create a fixed angle construct Note If cross threading occurs rotate the Nail Cap or Nail Cap Set Scre
31. ously described technique for blocking screw insertion ML blocking screw insertion In order to prevent anterior or posterior malalignment of the distal fragment blocking screws may also be placed 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 37 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 system insertion technique 38 Stability blocking screw insertion Following nail insertion and confirmati
32. rocedure refer to the blocking screws technique section pp 43 49 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 proximal femur 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 from the femoral 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 placement within the proximal femur 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 Retrograde Femoral 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 guide rod Implant length is read from the exposed calibrations at the end of the Ruler Note Implant length selection should take into consideration the fact that the nail must be countersunk past the articular surface of the distal femur Note Confirm that the Ruler opens easily and adjust the thumb wheel connection at the end to allow for free movement Radiographic templating is use
33. sired depth Femoral fractures should be treated with the longest nail possible in order to reduce the likelihood of stress risers Remove the guide rod once 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 24 Devices to lock distally Trauma Interface Cat No 7169 2802 TRIGEN SURESHOT Targeter sewer Cord Cat No 7169 2801 Cat No 6680 0193 AO Drill Bit Short Inner Drill Sleeve Long Cat No 7169 2810 Cat No 7169 1165 AO Drill Bit Long gt i Cat No 7169 2811 Outer Screw Sleeve Long Cat No 7169 1166 Hexdriver ee Cat No 7169 2809 Drill Sleeve Long Cat No 7169 2804 D au Drill Sleeve Short x Cat No 7169 2805 META Set Stop Cat No 7169 2806 META NAIL Standard Drill Guide Probe Cat No 7169 2814 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 measure
34. w counterclockwise until its threads line up with those of the nail Proceed with insertion until tight 40 Instruments for implant removal 3 2mm Tip Threaded Guide Wire Mini Connector Cat No 7163 1690 Cat No 7163 1186 12 5mm Entry Reamer f g i Cat No 7163 1116 Disposable Nail Extractor Cat No 7163 1320 Cannulated Impactor Medium Cannulated Impactor Long Cat No 7167 5081 Cat No 7163 1185 l 3 0mm x 1000mm Ball Tip Guide Rod Cat No 7163 1626 T handle Cat No 7167 4076 Medium Hexdriver Slotted Hammer Cat No 7163 1066 Cat No 7167 4082 Additional guide rods listed on page 52 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 Nail extraction optional Standard technique Remove the Nail Cap or Nail Cap Set Screw if implanted and all of the proximal locking screws with the Medium Hexdriver T handle assembly Remove all of the distal locking screws except for one in the same manner Thread the Extraction Bolt 7163 1320 into the Cannulated Impactor Medium 7167 5081 or Cannulated Impactor Long 7163 1185 and introduce the extraction assembly into the end of the nail Remove the remaining distal locking screw and then e
35. xtract 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 proximal locking screws and all but one of the distal locking screws as previously described Under fluoroscopy insert a 3 2mm Tip Threaded Guide Wire 7163 1690 into the end of the nail on power or by hand Make a 2cm incision around the Wire and advance the 12 5mm Entry Reamer over the Wire and into the end 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 7163 1320 and then thread the assembly into the end of the nail Remove the remaining distal locking screw and then extract the nail with a back slapping motion Note The tip of the Entrv Reamer is straight for approximately Icm before flaring out It is this portion of the Entry Reamer that enters the top of the nail 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 located in the original TRIGEN Instrument Set 7163 1326 and the HFN Instrument Set 7170 0001 42 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 guid

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