Technique Guide. Variable Angle LCP TMT Fusion Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7.

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1 Technique Guide Variable Angle LCP TMT Fusion Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7.

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3 Table of Contents Introduction Variable Angle LCP TMT Fusion Plates 2.4 / Indications 4 Controlled Compression Technique 5 Screw Insertion Techniques 9 Surgical Technique Preparation: 1 st TMT Fusion Plates 10 Preparation: TMT Fusion Plates 11 Implantation 12 Implant Removal 23 Product Information Screws 24 Plates 26 Instruments 27 Synthes Biomaterials Overview 32 Image intensifier control Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended. Reprocessing, Care and Maintenance of Synthes Instruments For general guidelines, function control and dismantling of multi-part instruments, please contact your local sales representative or refer to: Synthes 1

4 Variable Angle LCP TMT Fusion Plates 2.4/2.7. Part of the Variable Angle LCP Forefoot/Midfoot System 2.4 / 2.7. Features and Benefits 1 st TMT Fusion Plates For the fusion of the 1 st TMT Joint Standard and large lengths Compression wire holes for preliminary fixation of the plate to the bone Designed for MTC joint To be placed medial, dorsal or medial/dorsal to the medial cuneiform and 1 st metatarsal Anatomic, low profile designed specifically for 1 st TMT arthrodesis Oblong combi-hole for plate positioning and compression 2 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

5 TMT Fusion Plate For the fusion of the 2 nd and 3 rd TMT Joint One size Compression feature Variable angle Minimized soft tissue irritation Compression holes used with compression wires and forceps allow for tactile compression up to 4 mm. Screw holes allow up to 15 off-axis screw angulation in all directions. Low profile plates with rounded edges and highly polished surface minimize soft tissue irritation. Synthes 3

6 Indications The 1 st TMT Fusion Plates of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7 are indicated for deformations of the first tarsometatarsal (TMT) joint (Hallux valgus) and fractures, nonunions and replantations of the first metatarsal bone, particularly in osteopenic bone. The TMT Fusion Plate of the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7 is indicated for deformations of the second and third tarsometatarsal (TMT) joint and fractures, deformations, nonunions and replantations of the second and third metatarsal bone, particularly in osteopenic bone. 4 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

7 Controlled Compression Technique The plates included in the Variable Angle LCP Forefoot / Midfoot System 2.4 / 2.7 aid in reconstructive foot surgery by allowing controlled compression with the use of compression wires and compression forceps. Compression feature Allows for up to 4 mm of compression Tactile compression Designed within the plate to minimize additional soft tissue dissection Allows for final screw fixation after compression is achieved Compression slot Compression wire hole Compression wires 1.6 mm diameter, 150 mm overall length Seven thread lengths: 10, 15, 20, 25, 30, 35 and 40 mm Stop feature allows for quick and easy preliminary plate fixation, which eliminates the need for plate holding forceps or another hand to hold the plate to the bone Spherical stop: Designed to be seated on top of compression wire holes and compression slots, and inside variable angle LCP holes Allows for off-axis wire insertion while maintaining the compression feature capability Material: Cobalt chromium alloy that is stiffer than conventional stainless steel Spherical stop Compression forceps Spherical shaped recess matches the spherical stops on the compression wires, which ensures the forceps grasp the stops regardless of the angle in which the wires were inserted Locking ratcheting mechanism holds compression during insertion of fixation screws Simple lightweight design does not require holding during insertion of fixation screws Synthes 5

8 Controlled Compression Technique 1 Position plate Place the plate on the bone, ensuring that the plate is placed appropriately according to the specific procedure. 6 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

9 2 Insert compression wires Instrument Compression Wire 1.6 mm, length 150 mm, thread length mm Estimate the appropriate thread length needed for the plate and bone combination. Bicortical fixation is recommended. Using a wire driver, insert the compression wire through the compression wire hole and through both bone cortices. Important: To minimize stripping of the bone threads, slow the insertion once the sphere of the wire gets close to the plate. Slowly control the insertion to achieve good compression of the wire to the plate and to the bone. High power insertion and stripping of the bone threads can lead to loosening of the compression wires and reduced compression. Insert the second compression wire into the far side of the slot. Synthes 7

10 Controlled Compression Technique 3 Compress using forceps Instrument Compression Forceps for use with Compression Wire Move the ratcheting switch so the forceps ratchet when closing preventing the spring from opening the forceps. Place the compression forceps in position, ensuring that the arms are around the compression wire spheres. Compress by squeezing the handles. Important: Compression is tactile, but be careful not to over compress. This may cause the compression wires to strip out of the bone. When the ratcheting mechanism is in the correct position, compression can be maintained without holding the forceps. This leaves the hands free for image intensifier control of the compression gap closure and for inserting final fixation screws. 8 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

11 Screw Insertion Techniques The plate holes of the Variable Angle LCP Technology 2.4 / 2.7 accept 2.4 mm and 2.7 mm Variable Angle (VA) Locking Screws. Screws can be inserted using two different techniques: Variable angle technique Pre-defined nominal angle technique Variable angle technique To drill variable angle holes at a +/-15 deviation from the nominal trajectory of the locking hole, insert the tip of the conical VA-LCP drill sleeve ( / ) and key into the cloverleaf design of the VA-LCP hole. VA-LCP drill sleeve, conical, for Drill Bits ( / ) Note: It is important not to angulate more than 15 from the central axis of the screw hole. Overangulation may result in difficulty while locking the screw and inadequate screw locking. Pre-defined nominal angle technique The fixed-angle VA-LCP drill sleeve ( / ) only allows the drill bit to follow the nominal trajectory of the locking hole. Use of funnel-shaped VA-LCP Drill Sleeve VA-LCP Drill Sleeve, coaxial, for Drill Bits ( / ) Synthes 9

12 Preparation: 1 st TMT Fusion Plates 1 Approach Make a dorsomedial incision medial to the extensor hallucis longus tendon (lateral to the tibialis anterior tendon). The incision should extend from the medial cuneiform to midshaft of the first metatarsal. Dissect down to the bone; isolate the medial branch of the superficial peroneal nerve. 2 Prepare joint surface Remove the cartilage and prepare the joint surface for fusion. The surface of the joint can be manipulated to achieve the desired correction. Note: Care should be taken to minimize joint surface removal to prevent shortening of the first ray. 3 Position plate Select the appropriate size plate and place the plate over the joint surface with the compression slot proximal to the joint. The plate can be placed medial or dorsal medial to the bone depending on anatomy and desired correction. The plate is designed with a pre-contour to help prevent medialization of the first metatarsal. A compression wire can be used to hold the plate in position. 10 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

13 Preparation: TMT Fusion Plates 1 Approach Make a long dorsal incision over the third metatarsal starting at the navicular and extending to the midshaft of the metatarsal. Identify and retract the dorsalis pedis artery and nerve. Dissect down to the bone. 2 Prepare joint surface Remove the cartilage and prepare the joint surface for fusion. The surface of the joint can be manipulated to achieve the desired correction. Note: Care should be taken to minimize joint surface removal to prevent shortening of the 2 nd and 3 rd ray. 3 Position plate Place the plate dorsally over the joint surface with the compression slot distal to the joint. The plate is designed with a pre-contour for an anatomic fit. A compression wire can be used to hold the plate in position. Synthes 11

14 Implantation The implantation is the same technique for the 1 st TMT Fusion Plates and the TMT Fusion Plate. This technique is shown in the following section with the 1 st TMT Fusion Plate. 1 Apply reduction and compression Instruments Compression Forceps for use with Compression Wire Compression Wire 1.6 mm, length 150 mm, thread length 10 mm Compression Wire 1.6 mm, length 150 mm, thread length 15 mm Compression Wire 1.6 mm, length 150 mm, thread length 20 mm Compression Wire 1.6 mm, length 150 mm, thread length 25 mm Compression Wire 1.6 mm, length 150 mm, thread length 30 mm Compression Wire 1.6 mm, length 150 mm, thread length 35 mm Compression Wire 1.6 mm, length 150 mm, thread length 40 mm If required, compression may be achieved as described in the Controlled Compression Technique section (p. 5) of this technique guide. It is recommended to insert an independent lag screw to aid in stabilization. Insert the screw obliquely across the plantar aspect of the TMT joint. 12 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

15 2 Insert independent cortex screw Instruments cortex screws 2.7 mm Drill Bit 2.0 mm, with marking, length 110/85 mm, 2-flute, for Quick Coupling Drill Bit 2.7 mm, length 100/75 mm, 2-flute, for Quick Coupling Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Screwdriver Shaft, Stardrive, T8, self-holding Instruments cortex screws 2.4 mm Drill Bit 1.8 mm, with marking, length 110/85 mm, 2-flute, for Quick Coupling Drill Bit 2.4 mm, length 100/75 mm, 2-flute, for Quick Coupling Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Screwdriver Shaft, Stardrive, T8, self-holding Synthes 13

16 Implantation Insert an additional independent cortex screw depending on the corresponding indication and situation. For compression of the additional independent screw it is recommended to use the lag screw technique. For 2.4 mm cortex screws, use the 2.4 universal drill guide and pre-drill the screw hole with the 1.8 mm drill bit. For 2.7 mm cortex screws, use the 2.7 universal drill guide and pre-drill the screw hole with the 2.0 mm drill bit. To drill a gliding hole for compression, use the 2.7 mm drill bit (for 2.7 mm cortex screw) or the 2.4 mm drill bit (for 2.4 mm cortex screw) with the double drill guide. Determine the screw length with the depth gauge and insert the screw. 14 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

17 3 Pre-drill for VA locking screws Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm VA-LCP Drill Sleeve 2.7, coaxial, for Drill Bits 2.0 mm Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm VA-LCP Drill Sleeve 2.4, coaxial, for Drill Bits 1.8 mm Universal Drill Guide Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Determine the size of screws to be used, 2.4 or 2.7 mm, and whether they will be inserted at a variable angle (3a) or at the pre-defined nominal angle (3b). Synthes 15

18 Implantation 3a Pre-drill using variable angle technique Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Variable angle locking screws allow for manipulation around the independent lag screw. Insert and lock the VA-LCP drill sleeve tip into the cloverleaf design of the VA-LCP hole. The cone will self retain in the hole. 16 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

19 Use the 2.0 mm drill bit (2.7 mm VA screw) or the 1.8 mm drill bit (2.4 mm VA screw) to drill at the desired angle and to the desired depth. The cone of the drill sleeve allows the drill bit to be angled up to 15 around the central axis of the locking hole. Important: To ensure that the drill guide is locked correctly, do not angle the drill bit in excess of +/ 15 from the nominal trajectory of the hole. To achieve the desired angle, verify the drill bit angle and depth under image intensification. If incorrect, drill at a different angle and verify again under image intensification. Use the according depth gauge to measure the correct screw length. Synthes 17

20 Implantation 3b Pre-drill using pre-defined nominal angle technique Instruments VA screws 2.7 mm Drill Bit 2.0 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.7, coaxial for Drill Bits 2.0 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Optional instrument Universal Drill Guide 2.7 Instruments VA screws 2.4 mm Drill Bit 1.8 mm, with marking, length110/85 mm, 2-flute, for Quick Coupling VA-LCP Drill Sleeve 2.4, coaxial for Drill Bits 1.8 mm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Optional instrument Universal Drill Guide 2.4 Variable angle locking screws and standard locking screws can be inserted into the plate at the predefined hole angle or coaxial. 18 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

21 Insert and lock the VA-LCP drill sleeve tip into the cloverleaf design of the VA-LCP hole. The coaxial drill guide will self retain in the hole. Use the 2.0 mm drill bit (for VA locking screw and standard 2.7 mm locking screws) or the 1.8 mm drill bit (for VA locking screw and standard 2.4 mm locking screws) to drill to the desired depth. Verify the drill bit depth under image intensification. Use the according depth gauge to measure the correct screw length. Synthes 19

22 Implantation 4 Insert VA locking screws Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Handle with Quick Coupling, length 110 mm or Handle with Quick Coupling Insert the correct length variable angle locking screw manually using the screwdriver shaft and handle with quick coupling. Insert the screw until the screw head is seated (with limited force) in the variable angle locking hole. Important: Do not over-tighten screws. This allows the screws to be easily removed should they not be in the desired position. Insert additional screws as needed. Confirm proper reconstruction, screw placement and screw length under image intensification. 20 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

23 5 Lock VA locking screws Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Torque Limiter, 1.2 Nm, with AO/ASIF Quick Coupling Handle for Torque Limiters 0.4/0.8/1.2 Nm Use the 1.2 Nm torque limiting attachment (TLA) to perform the final locking step for variable angle locking screws. The torque limiting attachment attaches to the T8 Stardrive screwdriver shaft and the blue handle of the torque limiting attachment. After appropriate screw angle and screw length has been finalized, manually insert the screw using the TLA assembly. Use of the TLA is mandatory for variable angle locking holes to ensure the correct amount of torque is applied when inserting the screws. With this final locking step, the screws are securely locked in the plate to achieve maximum strength of the plate-screw inter face. Remove the compression wires. Synthes 21

24 Implantation 6 Ensure proper reconstruction Ensure proper joint reconstruction, screw placement and screw length under image intensification. Verify that the screws are not in the soft tissue 22 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

25 Implant Removal Instruments VA screws 2.4/2.7 mm Screwdriver Shaft, Stardrive, T8, self-holding Handle with Quick Coupling To remove locking screws, first unlock all locking screws before removing them completely. Otherwise, the plate may rotate and damage the soft tissue. Synthes 23

26 Screws Variable angle locking screws (VA-LCP) 2.7 mm 0X VA Locking Screw Stardrive 2.7 mm 040 (head 2.4), self-tapping, length mm 0X S 060S VA Locking Screw Stardrive 2.7 mm (head 2.4), self-tapping, length mm, sterile Threaded, rounded head locks securely into the threaded VA-LCP holes to provide angular stability at angles determined by the surgeon. Also securely locks into standard locking holes (LCP) of the plate at the pre-defined angle. Important: For final locking, the 1.2 Nm TLA torque limiting attachment is required. Optional: Variable angle locking screws (VA-LCP) 2.4 mm 0X VA Locking Screw Stardrive 2.4 mm, 140 self-tapping, length 6 40 mm 0X S 160S VA Locking Screw Stardrive 2.4 mm, self-tapping, length mm, sterile All non-sterile screws are also available sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN 24 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

27 Cortex screws 2.7 mm X Cortex Screw Stardrive 2.7 mm, 900 self-tapping, length mm X02.962S 969S Cortex Screw Stardrive 2.7 mm, self-tapping, length mm, sterile Cortex screws 2.4 mm X Cortex Screw Stardrive 2.4 mm, 790 self-tapping, length 6 40 mm 0X S 960S Cortex Screw Stardrive 2.4 mm, self-tapping, length mm, sterile For use in round or combi-holes. Optional: Locking head screws 2.4/2.7 mm X Locking Screw Stardrive 2.4 mm, 830 self-tapping, length 6 30 mm X Locking Screw Stardrive 2.7 mm 260 (head LCP 2.4), self-tapping, length 6 60 mm All non-sterile screws are also available sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN Synthes 25

28 Plates 1 st TMT Fusion Plates 2.4/2.7, VA locking Art. No. Length (mm) Size 0X Standard 0X Long TMT Fusion Plate 2.4/2.7, VA locking Art. No. Length Holes Holes (mm) shaft head 0X All plates are available non-sterile and sterile packed. Add suffix S to article number to order sterile product. X= 2: Stainless steel X = 4: TAN 26 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

29 Instruments Handle with Quick Coupling, length 110 mm Screwdriver Shaft, Stardrive, T8, self-holding Torque Limiter, 1.2 Nm, with AO / ASIF Quick Coupling Handle for Torque Limiters 0.4 / 0.8 / 1.2 Nm Depth Gauge for Screws 2.0 to 2.7 mm, measuring range up to 40 mm Handle with Quick Coupling Holding Pin for VA Locking Plates 2.4 / 2.7 Synthes 27

30 Instruments Instruments for insertion of 2.7 mm screws Drill Bit 2.7 mm, length 100 / 75 mm, 2-flute, for Quick Coupling Drill Bit 2.0 mm, with marking, length 110 / 85 mm, 2-flute, for Quick Coupling Universal Drill Guide VA-LCP Drill Sleeve 2.7, conical, for Drill Bits 2.0 mm VA-LCP Drill Sleeve 2.7, coaxial, for Drill Bits 2.0 mm 28 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

31 Instruments for insertion of 2.4 mm screws Drill Bit 1.8 mm, with marking, length 110/85 mm, 2-flute, for Quick Coupling Drill Bit 2.4 mm, length 100/75 mm, 2-flute, for Quick Coupling Universal Drill Guide VA-LCP Drill Sleeve 2.4, conical, for Drill Bits 1.8 mm VA-LCP Drill Sleeve 2.4, coaxial, for Drill Bits 1.8 mm Synthes 29

32 Instruments Instruments for compression Compression Forceps for use with Compression Wire Compression Wire 1.6 mm, length 150 mm, thread length 10 mm Compression Wire 1.6 mm, length 150 mm, thread length 15 mm Compression Wire 1.6 mm, length 150 mm, thread length 20 mm Compression Wire 1.6 mm, length 150 mm, thread length 25 mm Compression Wire 1.6 mm, length 150 mm, thread length 30 mm Compression Wire 1.6 mm, length 150 mm, thread length 35 mm Compression Wire 1.6 mm, length 150 mm, thread length 40 mm 30 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

33 Additional instrument Bending Pliers for VA Locking Plates Synthes 31

34 Synthes Biomaterials Overview Synthetic and allogenic bone replacement materials have the advantage of uniform quality, unlimited availability and absence of potential complications at a donor site. Additionally, the application of synthetic and allogenic bone graft substitutes reduces the duration of the surgery. Synthes offers a wide range of synthetic biomaterial products in different application forms and with distinct biological properties: chronos chronos Perfusion Concept chronos Inject Osteoconductive, resorbable, synthetic Enhancing chronos with biological factors Injectable remodelling Norian SRS DBX* Injectable stability Osteoinductive power *Facilitated through Synthes Furthermore a comprehensive portfolio of allograft products is available in selected countries. For more detailed information about a specific product or availability of allografts please contact your local Synthes representative. 32 Synthes Variable Angle LCP TMT Fusion Plates 2.4 / 2.7 Technique Guide

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36 01/ Synthes, Inc. or its affiliates Subject to modifications Synthes, LCP and Stardrive are trademarks of Synthes, Inc. or its affiliates Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf All technique guides are available as PDF files at Ö öAA?ä version AA rev. 1

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