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TRIGEN Humeral Nail

1. In order to avoid impingement of the biceps tendon it is a good idea to start with the proximal anterolateral locking screw Place the 3 2mm Silver Inner Drill Sleeve 7175 1116 into the Gold Outer Sleeve 7175 1128 Insert the Sleeve unit into the Proximal Drop 7175 1131 The Trocar 7175 1136 can be inserted into the sleeve unit to determine the exact location for the insertion of the locking screw If the Trocar tip indicates the proximal anterolateral screw is in line with the bicipital groove reorient the nail to avoid impingement Once proper alignment has been achieved make a stab incision and push the sleeve unit down to the bone Use the Trocar to dimple the cortex Remove the Trocar from the sleeve unit and drill through the near cortex stopping at the articular surface of the far cortex using the 3 2mm Graduated Two Flute Drill 7175 1149 Take the length measurement from the calibrations on the drill or the Screw Depth Gauge 7175 1139 The 3 2mm Silver Inner Drill Sleeve must be removed from the Gold Outer Sleeve in order to use the Screw Depth Gauge 32 Surgical Technique Proximal locking screws Remove the 3 2mm Silver Inner Drill Sleeve 7175 1116 and insert the 3 5mm Hex Driver 7175 1140 with the appropriate length 5 0mm Cancellous Screw attached The head of the screw should be nearly seated when the laser marked ring on the 3 5mm Hex Driver is even with the Gold Outer Sleeve 7175 1128 Final se
2. Catalog information TRIGEN 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 TAN Set Stop 7169 2808 Field Accuracy Gauge 7169 2809 Hexdriver 7169 2816 TAN Anteversion Locking Guide 7169 2830 Targeting Instrument Tray 7169 2831 Targeting Instrument Tray Lid TRIGEN SURESHOT Humeral Instrument Set Set No 7165 1100 Cat No Description Qty 7169 1151 SURESHOT Humeral Set Stop 1 7169 1153 SURESHOT Humeral 3 5mm Hexdriver 1 7169 1154 SURESHOT Humeral 3 2mm Drill Sleeve 2 7169 1156 SURESHOT Humeral Instrument Caddy 1 TRIGEN SURESHOT Humeral Disposable Set Set No 7165 1101 Cat No Description Qty se 7169 1152 SURESHOT Humeral Drill Guide Probe 2 RS 7169 1155 SURESHOT Humeral 3 2mm AO Drill 2 42 Catalog information TRIGEN SURESHOT Instruments TRIGEN SURESHOT Country Kit North America TRIGEN SURESHOT Country Kit Italy Cat No 7165 7003 Cat No 7165 7009 Cat No Description Qty Cat No Description Qty 6680 0193 Power Cord 125 Volt 10 Amp North 1 6680 0291 Power Cord 250 Volt 10 Amp 1 America Hospital Grade Continental Europe 7118 1927 User Manual English 1 7118 1536 User Manual Italian 1
3. TRIGEN SURESHOT Country Kit Additional Country Kits United Kingdom Cat No 7165 7011 TRIGEN SURESHOT Country Kit Australia Cat No Description Qty Cat No 7165 7004 6680 0213 Power Cord 250 Volt 10 Amp UK 1 Cat No Description Qty 7118 1927 User Manual English 1 6680 0303 Power Cord 250 Volt 10 Amp 1 Australia NZ 7118 1927 User Manual English 1 TRIGEN SURESHOT Country Kit South Africa India TRIGEN SURESHOT Country Kit Continental ANSE Europe Cat No Description Qty Cat No 7165 7005 6680 0302 Power Cord 250 Volt 10 Amp 1 Cat No Description Qty scree l 6680 0291 Power Cord 250 Volti0 Amp 1 7118 1927 User Manual English l 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 User Manual Spanish 1 43 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 and 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 01363 V1 71181802 REVB 01 14
4. Tip The back of a standard AO MiniConnector 7175 1153 may be used as a lever to release the set stop from the drill guide if overtightened n mee e TRIGEN SURESHOT Dark Green probe Humeral Nail Drill Use only with Guide Probe Humeral Drill Guide 7169 1152 7175 1129 Set the probe to the length of the TRIGEN IM Nail Note Verify the probe is oriented correctly in the set stop notches should face laterally If the probe is rotated 180 it will not be accurate For Humeral notches should face laterally Note The probe is bent for easier insertion Do not Straighten it as this may cause inaccuracy or even missing the lock Probe connection Connect the probe to either of the probe sensor ports on the Trauma Interface 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 23 Surgical procedure TRIGEN SURESHOT system
5. acromion to the edge of the head of humerus anterolateral to the tip of the acromion The deltoid is divided down to the sub deltoid bursa The deltoid muscle is then retracted Visualize the rotator cuff insertion into the greater tuberosity The biceps tendon is palpated anteriorly The rotator cuff supraspinatus tendon is incised 15 20mm in line with its fibers exposing the humeral head Insert suture into the rotator cuff interval to retract the rotator cuff and facilitate its repair after insertion of the nail Lateral portal Entry portal is made just medial to the tendon insertion and centered midway between the biceps groove anteriorly and the posterior humeral head Central portal straight proximal nail Entry portal is made at the apex of the humeral head and centered midway between the biceps groove anteriorly and the posterior humeral head Central Portal Lateral Portal Surgical Technique Entry Tool and Guide Pin placement The rotator cuff is divided to expose the superior portion of the humeral head The Entry Cuff Guard 7175 1100 protective device should be used to retract the soft tissue of the rotator cuff for visualization of the bone The Cuff Guard provides a visual working channel while protecting the rotator cuff and soft tissue during the procedure Attach the 3 2mm Tip Threaded Guide Pin 7175 1147 or Trocar 7175 1136 to the Mini Connector with Handle 7175 1133 Place through the
6. 3 5mm Hex Driver 7175 1140 The screw is inserted through the Gold Outer Sleeve 7175 1128 using the 3 5mm Hex Driver Final tightening of the screw should always be performed manually using the Straight Ratcheting Driver 7175 1141 Repeat this process for the inferior distal screw 35 Surgical Technique Closure Close the wound in layers use nonresorbable sutures in the rotator cuff repair Close the remainder of the incision in a standard fashion Removal of the nail The Screw Head Trephine 7175 1144 the Proximal Nail Trephine 7175 1143 and the Extractor 7175 1142 are included in the instrument set to facilitate nail removal 36 Catalog information TRIGEN Humeral Nail Implants TRIGEN Humeral Nail Implant Set Set No 7175 0703 TRIGEN Humeral Nail Cap Not Shown Cat No 7176 0000 TRIGEN Proximal Straight Humeral Nail Cat No 7176 0816 Size 8 7mm Length 16cm TRIGEN Proximal Bent Humeral Nail Cat No 7177 0816 Size 8 7mm Length 16cm TRIGEN Long Bent Humeral Nail Cat No Size Length 7177 0818 7177 0820 7177 0822 7177 0824 7177 0826 7177 0828 7177 0918 7177 0920 7177 0922 8 7mm 8 7mm 8 7mm 8 7mm 8 7mm 8 7mm 9 7 5mm 9 7 5mm 9 7 5mm 18cm 20cm 22cm 24cm 26cm 28cm 18cm 20cm 22cm Cat No Size Length 7177 0924 7177 0926 7177 0928 7177 1018 7177 1020 7177 1022 7177 1024 7177 1026 7177 1028 9 7 5mm 9 7 5mm 9 7 5mm 10 8 5mm 10 8
7. 5mm 10 8 5mm 10 8 5mm 10 8 5mm 10 8 5mm 5 0mm Self Tapping Cancellous Screw Cat No Length Cat No Length 7175 5024 7175 5026 7175 5028 7175 5030 7175 5032 7175 5034 7175 5036 7175 5038 7175 5040 7175 5042 7175 5044 4 0mm Self Tapping Cortical Screw Cat No Length Cat No Length 7175 4020 7175 4022 7175 4024 7175 4026 7175 4028 7175 4030 24mm 26mm 28mm 30mm 32mm 34mm 36mm 38mm 40mm 42mm 44mm 20mm 22mm 24mm 26mm 28mm 30mm 7175 5046 7175 5048 7175 5050 1145 3052 7175 5054 7175 5056 7175 5058 7175 5060 7175 5062 7175 5064 7175 4032 7175 4034 7175 4036 7175 4038 7175 4040 46mm 48mm 50mm 52mm 54mm 56mm 58mm 60mm 62mm 64mm 32mm 34mm 36mm 38mm 40mm 24cm 26cm 28cm 18cm 20cm 22cm 24cm 26cm 28cm 37 Catalog information TRIGEN Humeral Nail Instruments TRIGEN Humeral Nail Instrument Set Set No 7175 1150 Entry Cuff Guard Cat No 7175 1100 Disposable Cuff Guard Cat No 7175 1101 3 2mm Tip Threaded Guide Pin Cat No 7175 1147 Trocar Cat No 7175 1136 Mini Connector with Handle Cat No 7175 1137 Straight Entry Reamer Cat No 7175 1103 Small Hammer Cat No 7175 1135 Humeral Nail Guide Bolt Cat No 7175 1108 Nail Drill Guide Cat No 7175 1129 Guide Bolt Wrench Cat No 7175 1134 Catalog information TRIGEN Humeral Nail Instruments F image not shown Impactor Cat No
8. 7175 1133 Straight Reducer Cat No 7175 1105 Straight Ratcheting Driver Cat No 7175 1141 2 0mm x 600mm Graduated 3 2mm Ball Tip Guide Rod Cat No 7175 1146 Obturator Cat No 7175 1145 Ruler Cat No 7175 1126 Fixed Endcutting Reamers Size Cat No 6 0mm 7111 8220 7 0mm 7111 8222 8 0mm 7111 8224 9 0mm 7111 8226 10 0mm 7111 8228 11 0mm 7111 8230 Proximal Drop Cat No 7175 1131 Anterior Stylus Cat No 7175 1130 3 2mm Silver Inner Drill Sleeve Cat No 7175 1116 Dedicated to Humeral nail only cannot be used with other TRIGEN systems HFN 39 Catalog information TRIGEN Humeral Nail Instruments as ee ee ES 40 Gold Outer Sleeve Cat No 7175 1128 3 2mm Graduated Two Flute Drill Description Cat No Short 7175 1148 Long 7175 1149 Screw Depth Gauge Cat No 7175 1139 3 5mm Hex Driver Cat No 7175 1140 AO Mini Connector Cat No 7175 1153 Mini Connector Cat No 7163 1186 Trinkle Connector Cat No 7163 1187 Screw Head Trephine Cat No 7175 1144 Proximal Nail Trephine Cat No 7175 1143 Extractor Cat No 7175 1142 Cannulated Awl Cat No 7175 1102 Catalog information TRIGEN Humeral Nail Instruments Screw Length Sleeve Cat No 11 0238 Top Instrument Tray Cat No 7175 1151 Bottom Instrument Tray Cat No 7175 1152 Case Cat No 7112 9400 Case Lid Cat No 7112 9402 Reamer Cassette Cat No 7175 1156 4
9. distal VOU seri T 28 ON EO e deste tee E E ee esate sore 29 Instruments for proximal locking distal locking and freehand distal locking of Proximal 16cm Humeral Nails 30 Distal locking screws for TRIGEN Proximal 16cm Humeral Nails 31 Proximal locking screws 32 Distal locking screws without the use of TRIGEN SURESHOT 35 NS CS E E O AA E E E E ETA 36 Catalog information oo cece cccceceeceeeceeeeeceeeeeeeeeeseeeeseeeeaeees 37 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 2 Introduction Uncover an easy and advanced nailing system The TRIGEN Humeral Nail provides new possibilities for the treatment of proximal humeral fractures and humeral shaft fractures With multiplanar screws that are threaded into the nail to inhibit proximal screw back out and effective simple instrumentation that helps protect soft tissues the TRIGEN system now offers an effective intramedullary nail for humeral fracture management Introduction TRIGEN Humeral Nail indications Two part fractures of the humerus Three part fractures of the humerus Midshaft Diaphyseal Fracture s Segmental Humerus Fracture s Introduction TRIGEN SURESHOT indications Legend Important warnings a
10. humerus Read the nail length from the calibrations exposed at the other end of the Ruler The 2 0mm Graduated Ball Tip Guide Rod has graduated markings and can be used to determine required implant length The Straight Reducer 7175 1105 can also be used to determine implant length by using the markings on the reducer shaft Both options are used to directly measure to the articular surface taking care to ensure the nail will be slightly countersunk Additional limited reaming Necessary for Proximal Nails longer than 8mm X 16cm After the nail length has been determined additional limited reaming can be performed to avoid nail incarceration and distraction at the fracture site during insertion of the nail Begin with the 6 0mm Fixed Endcutting Reamer 7111 8220 to 7111 8230 and insert it over the 2 0mm Graduated Ball Tip Guide Rod Ream the intramedullary canal sequentially Be careful not to push the guide rod distally during reaming Never insert a nail that has a larger diameter than the last reamer used It is recommended that templating is done for all cases to estimate the size of the implant needed The diameter of the last reamer used will help determine the diameter of the implant needed Keep in mind that all of the nail sizes taper and the canal should be reamed to Imm over the implant diameter Surgical Technique Instruments for nail assembly and insertion CCC Humeral Nail Guide Bolt Ca
11. set up Drill sleeve selection Select the 3 2mm humeral drill sleeve 7169 1154 Implant selection screen Select the TRIGEN IM Nail and size that will be used Humeral 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 drop down menu OR by pressing the implant tab located in the lower left corner of the navigation screen 24 Surgical procedure after IM Nail Assembly to the Drill Guide Drill sleeve attachment Tightly secure the selected drill sleeve to the Targeter Note The Humeral Drill Sleeve 7169 1154 can be loosened from the targeter using the slot in the TRIGEN Slotted Hammer 7175 1135 29 Surgical Technique Skin incision with TRIGEN SURESHOT Skin incision Use the serrated tip of the SURESHOT Humeral 3 2mm Drill Sleeve 7169 1154 to identify where to make the incision The tip is at the right position when the green circle is aligned with the desired hole on screen Make the incision and place the tip of the drill sleeve down to bone where the green circle is aligned directly over the hole on the screen Note No X Rays are necessary 26 Surgical Technique Targeting the locking hole With the TRIGEN SURESHOT Humeral 3 2mm AO Drill 7169 1155 inserted into the TRIGEN SURESHOT Targeter 7169 2801 insert the tip of the SURESHOT Humeral 3 2mm Drill Sleeve 7169 1154 represe
12. Cuff Guard into the superior margin of the humeral head just medial to the greater tuberosity avoiding the rotator cuff insertion Verify position on the C arm to confirm guide pin placement is aligned in the medullary canal by oblique pictures at 45 with internal and external rotation of the shoulder Note The Disposable Cuff Guard 7175 1101 may be used to protect the rotator cuff while preparing the humerus for the nail The Nail can be inserted through the Disposable Cuff Guard A Drill Guide comes packaged with the Disposable Cuff Guard to facilitate the placement of the guide pin in the precise position Surgical Technique Instruments fracture reduction and reaming Straight Reducer Cat No 7175 1105 2 0mm Graduated Ball Tip Guide Rod Cat No 7175 1146 Ruler Cat No 7175 1126 Straight entry reamer Cat No 7175 1103 Straight Ratcheting Driver Cat No 7175 1141 Obturator Cat No 7175 1145 Fixed Endcutting Reamers image not shown Cat No 7111 8220 to 7111 8230 Cannulated Awl Cat No 7175 1102 15 Surgical Technique Prepare proximal section Insert the Straight Entry Reamer 7175 1103 over the 3 2mm Tip Threaded Guide Pin 7175 1147 or the Trocar 7175 1136 through the Entry Cuff Guard 7175 1100 and or the Disposable Cuff Guard 7175 1101 to prepare the humerus for the proximal section of the nail Ream until the cutting teeth are just below the articular surface of the humera
13. Screws thread into the nail to help prevent screw back out Introduction TRIGEN Humeral Nail specifications TRIGEN TRIGEN TRIGEN Humeral Nail 8 7mm x 16cm Humeral Nail 8 7mm x 16cm Long Bent Humeral Nail 8 7mm 9 7 5mm Proximal Bent Humeral Nail Proximal Straight Humeral Nail 10 8 5mm Diameter 18cm 28cm lengths by 2cm increments Trapezoidal 12mm x 10 5mm cross section Trapezoidal 12mm x 10 5mm cross section 35mm 80mm 30mm Proximal taper Proximal Taper First diameter First diameter 20mm measurement 8mm measurement 8mm 9mm or 10mm Proximal Taper Second diameter Measurement 7mm 20mm 10mm __ Second diameter measurement 7mm 7 5mm or 8 5mm Warnings and cautions for TRIGEN SURESHOT Referto theSUR ESHOTUs erM anuall 7118 1540 fora llw arnings c autions m aintenance c leaning and sterilization instructions Devices for system set up gt smith amp nephew SURESHOT Distal Targeting Systeam TRIGEN SURESHOT Targeter e Cat No 7169 2801 Trauma Interface Note The Targeter will be operated within the Cat No 7169 2802 Sterile field 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 safe to use Note If the Targete
14. TRIGEN Humeral Nail System Including TRIGEN SURESHOT Distal Targeting System Surgical Technique for the TRIGEN Humeral Nail System using the TRIGEN SURESHOT Distal Targeting System Table of contents Introduction 3 TRIGEN Humeral Nail indications 4 TRIGEN SURESHOT INOIC ATOS sasesdxureancee 5 TRIGEN Humeral Nail design rationale 0 0 0 0c ccecceceseeteteteeneees 6 TRIGEN Humeral Nail specifications 7 Warnings and cautions for TRIGEN SURESHOT c eee 8 Surgical Procedure OR OFS Al AIO a 9 Surgical Technique Paient DOS TONI ees 11 Instruments for opening the humerus 12 DOS nen senate E 13 Entry tool and guide pin placement 14 Instruments fracture reduction and reaming 15 Prepare proximal Section 16 Facture s 0 Ue 9 eeene mene ene anne nee E ne eee eee eee eee e 17 Measuring implant length 18 Additional UNIES ces 18 Instruments for nail assembly and insertion 19 Nail Drill Guide assembly 0 0 cece cece ceccesceesecsseessecnseeseseneeenes 20 PN SO EEE 21 Final version adjustment ccc ccc ccsccesccescessceesccsseessecseesseeseeenes 22 TRIGEN SURESHOT system set Up 23 IM Nail assembly drill guide oo cece ce ceecteeeeeecneeeeseeeeteeeesees 25 Skin incision with TRIGEN SURESHOT eccceceeceseteeteteteeteeee 26 Targeting the locking hole 27 DRE De
15. ating of the screw should always be under manual control using the Straight Ratcheting Driver 7175 1141 to avoid over insertion of the screw in soft bone Insert the remaining two proximal locking SCrews 33 Surgical Technique Proximal locking screws To target the proximal anterior locking hole remove the Anterior Stylus 7175 1130 and attach the Proximal Drop 7175 1131 on the anterior arm of the Nail Drill Guide 7175 1129 Caution Locate biceps tendon prior to beginning placement of the anterior screw Insert the 3 2mm Silver Inner Drill Sleeve 7175 1116 into the Gold Outer Sleeve 7175 1128 Insert the sleeve unit into the hole marked Anterior on the Proximal Drop Follow the same procedure described previously to drill measure and insert the Anterior and Posterior Proximal Screws 34 Surgical Technique Distal locking screws without the use of TRIGEN SURESHOT Freehand locking Distal locks on all nails 18cm and longer should be done using the freehand technique The Screw Length Sleeve 11 0238 can be used with the 3 2mm Graduated Two Flute Drill 7175 1149 to drill for the A P distal locks Length measurements can be made by using the graduations on the drill against the Screw Length Sleeve The Screw Depth Gauge 7175 1139 could also be used to determine the appropriate screw length Once the appropriate length 4 0mm Self Tapping Cortical Screw is selected it is attached to the
16. ctions connect the TRIGEN SURESHOT Targeter 7169 2801 to the Targeter port on the Trauma Interface SURESHOT Probe SURESHOT Targeter 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 Surgical Technique Patient positioning Supine position Position the patient supine with three liter bags of saline between scapulas Tilt the patient on the fluoroimage table so that the humerus may be extended posteriorly The C arm may be positioned either superior to the shoulder or opposite the shoulder if the C arm modus is large enough Alternati
17. e Rod from the top of the Nail Drill Guide 7175 1129 Confirm that the fracture is compacted and not distracted 21 Surgical Technique Final version adjustment Final and rigid version adjustment to the nail can be performed prior to inserting the proximal locking screws by attaching the Anterior Stylus 7175 1130 to the anterior arm of the Nail Drill Guide 7175 1129 Insert the Trocar 7175 1136 through the Anterior Stylus and position the nail so that the Trocar can be inserted into the lesser tuberosity at the location of the anterior locking hole Leave the Trocar in place to maintain fracture reduction and rotational stability during the insertion of the proximal lateral screws This step ensures that the proximal anterior and proximal anterolateral locking screws will not be inserted into the bicipital groove potentially injuring the biceps tendon Figure 16b Note When using the TRIGEN SURESHOT Distal Targeting System move the Anterior Stylus 7175 1130 to the lateral side of the Proximal Drop 7175 1131 after the final version is determined and insert a 3 2mm Tip Threaded Guide Pin 7175 1147 to provisionally secure the nail 22 Surgicalp rocedure TRIGEN SURESHOT system set up Probe assembly Insert the SURESHOT Humeral Drill Guide Probe 7169 1152 with the assembled SURESHOT Humeral Set Stop 7169 1151 through the Nail Drill Guide 7175 1129 and cannulation of the TRIGEN IM nail
18. h 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 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 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 Refer to the SURESHOT User Manual 7118 1540 for details about the SURESHOT Distal Targeting System Introduction TRIGEN Humeral Nail design rationale The TRIGEN Humeral Nailing System product offering includes a 16cm Proximal Straight Nail a 16cm Proximal Bent Nail and a full line of Long Bent Nails Nails with a proximal bend are best suited for simple two part fractures of the proximal humeru
19. l head The depth indicator on the reamer should be level with the top of the Cuff Guard Alternatively the Cannulated Awl 7175 1102 can be used with the Straight Ratcheting Driver 7175 1141 Surgical Technique Fracture reduction After removing the Straight Entry Reamer 7175 1103 and 3 2mm Tip Threaded Guide Pin 7175 1147 or Trocar 7175 1136 insert the Straight Reducer 7175 1105 attached to the Straight Ratcheting Driver 7175 1141 with the slot oriented toward the lateral cortex and reduce the fracture Place the tip of the finger off the medial cortex to help reduce the fracture To maintain reduction introduce the 2 0mm Graduated Ball Tip Guide Rod 7175 1146 through the Straight Reducer Center the Guide Rod 1 2cm proximal to the olecranon fossa in the distal end of the humerus Once the Guide Rod is in place carefully remove the Straight Reducer using the Obturator 7175 1145 as needed to ensure the Guide Rod stays in place Surgical Technique Measuring implant length To measure the length of the implant needed ensure that the distal tip of the 2 0mm Graduated Ball Tip Guide Rod 7175 1146 is located at the desired position of the distal tip of the nail Slide the Ruler 7175 1126 over the proximal end of the 2 0mm Graduated Ball Tip Guide Rod and advance the open end of the Ruler to where the proximal portion of the implant will be seated just below the articular surface of the proximal
20. nted by the green circle through the incision and down to bone Tibia shown in image 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 the serrated tip firmly against bone to keep the green circle static on the screen 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 Critical Verify there are no other metal objects including metal triangles in the field Metal interference will cause the system to be inaccurate Note The green circle must be fully within the hole of the IM nail displayed on the Trauma Interface screen to ensure accurate drilling 27 Surgical Technique Drilling distal hole Drill through near cortex and the nail using the TRIGEN SURESHOT Humeral 3 2mm AO Drill 7169 1155 Before drilling through far cortex obtain the screw measurement Note Important if standard 3 2mm Graduated Two Flute Drill 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 Meas
21. ppear 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 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 wit
22. r 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 the display prompts for tool conne
23. rget The Proximal Drop should be used to target the proximal screws on all Humeral Nails and the distal screws on the 16cm Proximal Nails Distal locking screws for the 18cm or longer Humeral Nails should be targeted using the TRIGEN SURESHOT Distal Targeting System or a freehand technique Refer to SURESHOT User Manual for the Field Accuracy check instructions Check with the TRIGEN SURESHOT Distal Targeting System 20 The Humeral Nail and Nail Drill Guide are keyed to ensure proper orientation of the nail on the Nail Drill Guide Surgical Technique Nail insertion At this point the nail is ready to be inserted Care should be taken to insert the nail with the correct amount of retroversion and depth in order to maximize locking screw fixation while avoiding critical soft tissues such as the biceps tendon axillary and radial nerves Insert the nail attached to the Nail Drill Guide Assembly over the 2 0mm Graduated Ball Tip Guide Rod 7175 1146 and through the Entry Cuff Guard 7175 1100 with the lateral arm of the drill guide oriented with approximately 30 35 of retroversion Adjustments to this version can be made so that the anterior arm of the drill guide is in line with the lesser tuberosity avoiding alignment with the bicipital groove Proper depth is achieved when the lateral ledge on the drill guide is above the lateral cortex and the nail is seated just below the articular surface Remove the Guid
24. s involving the surgical neck of the humerus and proximal third humeral fractures without comminution In these scenarios the proximal bend facilitates an easier entry portal attainment and nail insertion with an incision just medial to the rotator cuff insertion The Long Bent Humeral Nail is primarily indicated for humeral shaft fractures which are inherently not prone to varus malposition The lateral portal design allows insertion just medial to the rotator cuff insertion and facilitates easier portal attainment and nail insertion The 16cm Proximal Straight Humeral Nail offers the option of a medialized entry site If the greater tuberosity is fractured or compromised a straight centralized starting point avoids fracture extension from the tuberosity fracture into the entry portal and resultant loss of nail Stability The entry portal for the straight nail is slightly more difficult to attain than the curved nail entry portal Locking holes TRIGEN 8 7mm X 16cm Proximal Straight Humeral _ Nail offers an alternate choice in treating different fracture patterns Straight Humeral Nail 5 0mm Cancellous Proximal Locking Screws 24mm 64mm lengths 2mm increments Four multiplanar proximal locks improve fracture stability 4 degree proximal bend Long Bent Humeral Nail 4 0mm Cortical Distal Locking Screws 20mm 40mm lengths 2mm increments Proximal locking holes have innovative threaded design
25. t No 7175 1108 O Guide Bolt Wrench Cat No 7175 1134 b Proximal Drop Cat No 7175 1131 3 2mm Silver Inner Drill Sleeve Cat No 7175 1116 Anterior Stylus Cat No 7175 1130 Humeral Nail Drill Guide Probe Cat No 7169 1152 Nail Drill Guide Cat No 7175 1129 aj Impactor Cat No 7175 1133 Gold Outer Sleeve Cat No 7175 1128 3 2mm Long Graduated Two Flute Drill Cat No 7175 1149 enter permanen aa anaa aaan ae Trocar Cat No 7175 1136 19 Surgical Technique Nail Drill Guide assembly Once the implant selection is complete use the Humeral Nail Guide Bolt 7175 1108 to attach the Nail Drill Guide 7175 1129 to the nail The nail and Nail Drill Guide are keyed to ensure proper orientation of the nail on the Nail Drill Guide Note The metal threads on the proximal locking holes should always be lateral Tighten the Humeral Nail Guide Bolt using the Guide Bolt Wrench 7175 1134 The Impactor 7175 1133 is then attached to the Humeral Nail Guide Bolt To complete the assembly attach the Proximal Drop 7175 1131 to the lateral arm of the Nail Drill Guide Tighten the Proximal Drop to the Guide using the knurled knob Verify targeting accuracy by inserting a Gold Outer Sleeve 7175 1128 and 3 2mm Silver Inner Drill Sleeve 7175 1116 into the drop and passing a 3 2mm Long Graduated Two Flute Drill 7175 1149 through the assembly An incorrectly attached nail will not ta
26. the Gold Outer Sleeve 7175 1128 Insert the sleeve unit into the targeting hole in the Proximal Drop which corresponds to the superior M L distal locking hole in the nail While applying compression at the condyles of the elbow to reduce shaft fractures as needed make a stab incision and push the sleeve unit down to the bone The Trocar 7175 1136 in combination with the drill sleeve unit may be used to dimple the cortex Drill through both cortices using the 3 2mm Long Graduated Two Flute Drill 7175 1149 A length measurement can be taken from the calibrations on the drill against the 3 2mm Silver Inner Drill Sleeve or the Screw Depth Gauge 7175 1139 can be used through the Gold Outer Sleeve to measure for distal locking screws Once the appropriate length 4 0mm Self Tapping Cortical Screw is selected it is attached to the 3 5mm Hex Driver The screw is inserted through the Gold Outer Sleeve using the 3 5mm Hex Driver 7175 1140 The head of the screw should be nearly seated when the laser marked ring on the Hex Driver is even with the Gold Outer Sleeve Final tightening of the screw should always be performed manually using the Straight Ratcheting Driver 7175 1141 Repeat this process for the inferior distal screw 31 Surgical Technique Proximal locking screws Caution Do not countersink the nail such that proximal locking screws are below the level of the humeral head to avoid damage to the axillary nerve
27. urement Refer to User Manual Page 16 and 17 for drill depth measurements Picture shown with TRIGEN META NAIL 28 Surgical Technique Screw insertion Using the TRIGEN SURESHOT Hexdriver 7169 1153 the screw may be inserted using the Targeter WARNING The standard TRIGEN Hexdrivers are made trom magnetic stainless steel that will cause interference with the system and cannot be used 29 Surgical Technique Instruments for proximal locking distal locking of Proximal 16cm Humeral Nails and freehand distal locking Proximal Drop Cat No 7175 1131 3 2mm Silver Inner Drill Sleeve Cat No 7175 1116 ea en nn dm nn ten pe pen sate iret Trocar Cat No 7175 1136 Screw Depth Gauge Cat No 7175 1139 Straight Ratcheting Driver Cat No 7175 1141 30 Nail Drill Guide Cat No 7175 1129 Gold Outer Sleeve Cat No 7175 1128 3 2mm Long Graduated Two Flute Drill Cat No 7175 1149 3 5mm Hex Driver Cat No 7175 1140 Screw Length Sleeve Cat No 11 0238 Surgical Technique Distal locking screws for TRIGEN Proximal 16cm Humeral Nails Note The Proximal Drop 7175 1131 only targets the distal holes for the 16cm nails Nails longer than 16cm will be targeted using the freehand technique or TRIGEN SURESHOT Distal Targeting System With the Proximal Drop connected to the lateral arm of the Nail Drill Guide 7175 1129 place the 3 2mm Silver Inner Drill Sleeve 7175 1116 into
28. ve position Position the patient in a slight beach chair position The arm of the semi recumbent patient is left to hang near the trunk thus its weight helps reposition the humeral head anterior to the acromion The C arm is placed above the head of the table at 30 extending distally over the shoulder This will allow an anteroposterior view of the humerus The arm should be placed in reverse pushing position to clear the entry point anatomically located at the superior margin of the articular surface just medial to the greater tuberosity Once the correct positioning and imaging are assured the shoulder and arm are prepped and draped Surgical Technique Instruments for opening the humerus Entry Cuff Guard Cat No 7175 1100 el 3 2mm Tip Threaded Guide Pin Cat No 7175 1147 T Mini Connector with Handle Cat No 7175 1137 Cannulated Awl Cat No 7175 1102 12 l nu Disposable Cuff Guard Optional may be used in place of 7175 1100 Entry Cuff Guard Cat No 7175 1101 Trocar Cat No 7175 1136 ne Straight Entry Reamer Cat No 7175 1103 Straight Ratcheting Driver Cat No 7175 1141 Surgical Technique Incision The incision approach that is recommended and most often used for antegrade humeral nailing is the lateral deltoid splitting incision For complete fractures or nonunions a traditional deltopectoral approach may be used A 2 3cm incision is made from the edge of the

TRIGEN Humeral Nail

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