Stabilize the Phalanges and Metacarpals Mini External Fixator Surgical Technique
Table of Contents Introduction Mini External Fixator 2 Indications 4 Surgical Technique Technique Overview 5 Product Information Instruments 7 Set List 8 MR Information The Mini External Fixator has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Mini External Fixator in the MR environment is unknown. Scanning a patient who has this device may result in patient injury. Mini External Fixator Surgical Technique DePuy Synthes 1
Mini External Fixator Holding Clamps Two clamp sizes are laser-etched with one or two lines for easy identification. Allow sequential tensioning of Kirschner wires for reduced operative time. Slender design contributes to overall low-profile frame for improved patient comfort. 1.25 mm 1.6 mm 3.0 mm/3.0 mm Connecting Clamp Allows connection of 3.0 mm carbon fiber rods for the treatment of displaced intra-articular fractures. An additionally available 3.0 mm/ 4.0 mm connecting clamp allows bridging to DePuy Synthes Small External Fixator for treatment of complex hand and distal radius fractures. Threaded, trocar tip Kirschner wires in two sizes Provide more stability and better hold in cortical bone. Eliminate need to predrill, for reduced operative time. 1.25 mm and 1.6 mm diameters optimize adaptation to fracture patterns and patient anatomy. Laser-etched with one or two lines for easy identification. 1.25 mm 1.6 mm Angled Connecting Bar Allows lateral application of pins while maintaining a dorsal frame construct, as determined by the fracture pattern and surgeon preference. 2 DePuy Synthes Mini External Fixator Surgical Technique
Mini External Fixator Carbon Fiber Rods Lightweight for patient comfort Radiolucent for improved intra- and postoperative radiographic visualization Mini External Fixator Surgical Technique DePuy Synthes 3
Indications Comminuted fractures of phalanges and metacarpals Displaced intra-articular fractures Segmental bone loss Open fractures that do not allow stable internal fixation Fractures with associated complex soft tissue injuries Tumor resections 4 DePuy Synthes Mini External Fixator Surgical Technique
Technique Overview 1 Insert first K-wires Instruments 392.040 Hand Chuck for K-wires 395.902 1.25 mm/ 1.6 mm Protection Sleeve In each fragment, insert one threaded K-wire through the 1.25 mm/1.6 mm protection sleeve. The first two K-wires should be placed nearest to the fracture in each fragment. Precautions: Instruments and screws may have sharp edges or moving joints that may pinch or tear user s glove or skin. Handle devices with care and dispose of worn bone cutting instruments in an approved sharps container. Implant sites should be meticulously cared for to avoid pin-tract Infection. Wires may be surrounded with antiseptic coated foam sponges in an effort to avoid infection. An implant-site care procedure should be reviewed with the patient. To help minimize the risk of pin-tract infection the following points should be observed: a. Placement of K-wires taking anatomy into consideration (ligaments, nerves, arteries). b. Slow insertion and/or cooling, particularly in dense, hard bone to avoid heat necrosis. c. Release of skin tension at soft tissue entry point of implant. 2 Add clamps and rods Connect the appropriate clamp to each K-wire through the open hole of the clamp: 1.25 mm K-wires 1.25 mm Holding Clamp 1.6 mm K-wires 1.6 mm Holding Clamp Insert a 3.0 mm rod to connect the clamps. Reposition the fracture. Lightly tighten both clamp-to-pin and clamp-to-rod nuts, to provide sufficient stability for radiography and final fracture reduction. Mini External Fixator Surgical Technique DePuy Synthes 5
Technique Overview 3 Insert remaining K-wires Insert the two remaining K-wires, furthest from the fracture, using the remaining clamp holes as guides. Note: Make sure to occupy both openings of the holding clamps with a K-wire to ensure proper functioning of the clamps. 4 Secure all clamp nuts Instruments 395.139 Clamp Holder 395.304 Socket Wrench, 5.5 mm Using the clamp holder to avoid fracture displacement, retighten all nuts on both clamps. Cut the K-wires, if necessary. 6 DePuy Synthes Mini External Fixator Surgical Technique
Instruments 392.040 Hand Chuck, for K-wires 395.139 Clamp Holder 395.302 Combination Wrench, 5.5 mm width across flats 395.304 Socket Wrench, 5.5 mm 395.902 1.25 mm/ 1.6 mm Protection Sleeve Mini External Fixator Surgical Technique DePuy Synthes 7
Mini External Fixator Instrument and Implant Set (115.985) Graphic Case 304.564 Mini External Fixator Instrument and Implant Module Instruments 392.040 Hand Chuck, for K-wires 395.139 Clamp Holder 395.302 Combination Wrench, 5.5 mm width across flats 395.304 Socket Wrench, 5.5 mm 395.902 1.25 mm/ 1.6 mm Protection Sleeve Implants 292.600 1.25 mm K-wire with threaded tip, 100 mm, 1 pkg. (10/pkg.) 292.708 1.6 mm K-wire with threaded tip,100 mm, 1 pkg. (10/pkg.) Fixation Material 395.103 3.0 mm Angled Connecting Bar, 2 ea. 395.105 3.0 mm Carbon Fiber Rod, 25 mm, 2 ea. 395.107 3.0 mm Carbon Fiber Rod, 45 mm, 4 ea. 395.109 3.0 mm Carbon Fiber Rod, 60 mm, 4 ea. 395.111 3.0 mm Carbon Fiber Rod, 75 mm, 4 ea. 395.125 Holding Clamp, 1.25 mm, 6 ea. 395.126 Holding Clamp, 1.6 mm, 6 ea. 395.133 3.0 mm/ 3.0 mm Connecting Clamp, 4 ea. Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to www.synthes.com/cleaning-sterilization or sterilization instructions, if provided. 8 DePuy Synthes Mini External Fixator Surgical Technique
Also Available 292.71 1.6 mm Kirschner Wire with Thread, 150 mm, trocar point (10/ pkg.) 395.134 3.0 mm/ 4.0 mm Connecting Clamp 395.60 4.0 mm Carbon Fiber Rods 395.67 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, 160 mm, 180 mm, 200 mm 395.70 4.0 mm Connecting Bars (stainless steel) 395.77 60 mm, 80 mm, 100 mm, 120 mm, 140 mm, 160 mm, 180 mm, 200 mm Mini External Fixator Surgical Technique DePuy Synthes 9
Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information. CAUTION: Federal Law restricts these devices to sale by or on the order of a physician. Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada. Not all products may currently be available in all markets. Manufactured or distributed by: Synthes USA Products, LLC 1302 Wrights Lane East West Chester, PA 19380 Synthes USA, LLC 1101 Synthes Avenue Monument, CO 80132 To order (USA): 800-523-0322 To order (Canada): 855-946-8999 Note: For recognized manufacturer, refer to the product label. www.depuysynthes.com DePuy Synthes 1996 2017. All rights reserved. DSUS/TRM/1016/1170 6/17 DV