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Osseoti Porous Metal Foot and Ankle Reconstructive Wedge Surgical Technique Evans Protocol with Profile 1

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Osseoti Porous Metal Foot and Ankle Reconstructive Wedge Surgical Technique Evans Protocol with Profile 1 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Surgical Technique Evans Protocol with Profile 1 Inspired by Bone Table of Contents OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Evans Protocol with Profile 1 Surgical Technique Incision . 1 Osteotomy Cut . 2 Distraction . 2 Implant Insertion . 3 Ancillary Fixation with Plate . 5 Wound Closure and Post Operative Care . 5 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Evans Technique Figure 1 Figure 2 Incision Make an incision just below the sinus tarsi, extending Carefully reflect extensor digitorum muscle belly laterally approximately 3 cm proximal to the calcaneal- superiorly and retract the peroneal tendons along cuboid joint (Figure 1) . with the sural nerves inferiorly to expose the lateral calcaneal and calcaneocuboid joint (Figure 2) . This brochure is presented to demonstrate the OsseoTi Porous Metal Evans Foot and Ankle Reconstructive Wedges surgical technique utilized by Terrence Philbin, D .O . Biomet does not practice medicine and does not recommend any particular orthopedic implant or surgical technique for use on a specific patient . Each surgeon is responsible for determining the appropriate device and technique for each individual patient . 1 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Evans Technique Figure 3 Figure 4 Osteotomy Cut Distraction 10–12 mm proximal to the calcaneocuboid make an Place a 2 0. mm (or 1 6. mm) Steinmann pin on each side of osteotomy parallel to calcaneocuboid joint leaving the the osteotomy and utilize a distractor to aid in distraction medial cortex intact (Figure 3) . and access to the osteotomy site (Figure 4) . 2 Figure 5 Figure 6 Implant insertion Exchange colored trial inserters (start with smaller trials Connect the driver handle to inserter that corresponds to first then proceed with thicker/larger trials) into the the footprint of wedge determined during trial . Inserter distracted osteotomy site until the footprint matches will be same color as trial color . Attach the OsseoTi the size of the osteotomy site (Figure 5) . Assess whether Reconstruction Wedge as determined by trial implant appropriate correction occurs with wedge both clinically (Figure 6) . and fluoroscopically (shape and size) *. Note: Wedges may be used with allograft such as StaGraft products packed in the middle windows of the wedges . Use with handle is optional; however, coupling with the *In an extreme case where 11 mm thick implant is not handle provides more stability while inserting . sufficient, Biomet offers a 12 mm thickness . Trials are not offered for 12 mm thick wedges . 3 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Evans Technique Figure 7a Figure 8a Figure 7 Figure 8 Implant insertion (cont .) Seat the implant into the osteotomy site slightly recessed Connect proximal end of tamp to AO handle (Figure 8) . resting within the walls of the calcaneus (Figure 7, 7a) . Place tamp curve on outer skin of implant . Use hammer on distal end of handle to fine tune implant position Check final position fluoroscopically: 1) ensure the far (Figure 8a) . cortex is not compromised and 2) ensure adequate correction of deformity has occurred . If distractor is still in place, loosen and remove it . Ensure the wedge maintains good bone contact with each side of the osteotomy site . Release implant from inserter by holding down on engagement lever . Note: If additional fine tuning of implant positioning is needed, utilize tamp . 4 Figure 9 Wound Closure Ancillary Fixation with Plate and Post Operative Care Ancillary fixation is required when using OsseoTi After confirmatory AP and lateral X-rays, suture Reconstructive Wedges (Figure 9) . Refer to the A .L .P .S . individual layers of soft tissue . Follow appropriate post Total Foot Surgical Technique BMET0008 .4 for a operative protocol based on surgeon preference . detailed protocol . 5 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Implants Width Depth OsseoTi Porous Metal Foot and Ankle Wedge Sizing Thickness Profile 1 Footprint Thickness Part Number Width (mm) Depth (mm) Thickness (mm) Image Image 110003794 7 ** * 110003790 9 18 15 110003786 11 7 mm 110003784 12 110003782 7 * 110003778 9 21 17 .5 9 mm 110003774 11 110003772 12 110003770 7 * 11 mm 110003766 9 24 20 110003762 11 110003760 12 12 mm not shown *Image shown at actual size **Images shown at actual size for part numbers 110003770, 110003766, 110003762 Explant Information Remove the ancillary plate using the same plate-specific instrumentation used to implant the plate . Use forceps, or other desired general instruments to pull the wedge out . If necessary use an osteotome along the surface of the wedge-bone interface to free the wedge from the bone . 6 Instruments A B C D E F G H Product Label Part Number Size Description 110003909 18 x 15 x 7 A 110003905 18 x 15 x 9 Wedge Trial P1 18x15 110003901 18 x 15 x 11 B 110004029 18 x 15 Wedge Inserter P1 18x15 110003891 21 x 17 .5 x 7 C 110003887 21 x 17 .5 x 9 Wedge Trial P1 21x17 .5 110003883 21 x 17 .5 x 11 D 110004025 21 x 17 .5 Wedge Inserter P1 21x17 .5 110003873 24 x 20 x 7 E 110003869 24 x 20 x 9 Wedge Trial P1 24x20 110003865 24 x 20 x 11 F 110004021 24 x 20 Wedge Inserter P1 24x20 110003964 15 x 15 x 4 G 110003960 15 x 15 x 6 Wedge Trial P2 15x15 110003954 15 x 15 x 8 110003946 15 x 20 x 4 H 110003942 15 x 20 x 6 Wedge Trial P2 15x20 110003936 15 x 20 x 8 7 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedge Evans Technique Instruments (cont ). M K N L I J Product Label Part Number Size Description 110003928 15 X 25 X 4 I 110003924 15 X 25 X 6 Wedge Trial P2 15x25 110003918 15 X 25 X 8 J 110004033 15 Wedge Inserter P2 K 110005225 — AO Connect Handle L 010001467 — Closed Comp/Dist Instrument M 110004037 — Wedge Tamp N 27-361008 2 mm Steinmann Pin “Non-Sterile” (6/pk) OsseoTi Porous Metal Foot & Ankle — 597009 — Reconstruction Wedge Instrument Case Only OsseoTi Porous Metal Foot & Ankle — 597019 — Reconstruction Wedge Instrument Case Kitted 8 OsseoTi Porous Metal Foot and Ankle Reconstructive Wedges INDICATIONS Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as: • Open wedge osteotomies of Hallux Valgus • Evans lengthening osteotomies • Metatarsal/cuneiform arthrodesis Biomet Reconstructive Wedges are intended for use with ancillary fixation . Biomet Reconstructive Wedges are not intended for use in the spine . CONTRAINDICATIONS 1 . Infection 2 . Patient conditions including blood supply limitations, obesity, and insufficient quantity or quality of bone . 3 .Patients with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions . 4 .Foreign body sensitivity . Where material sensitivity is suspected, testing is to be completed prior to implantation of the device . 9 This material is intended for health care professionals and the Biomet sales force only . Distribution to any other recipient is prohibited . All content herein is protected by copyright, trademarks and other intellectual property rights owned by or licensed to Biomet Inc . or its affiliates unless otherwise indicated . This material must not be redistributed, duplicated or disclosed, in whole or in part, without the express written consent of Biomet . Check for country product clearances and reference product specific instructions for use . For complete product information, including indications, contraindications, warnings, precautions, and potential adverse effects, see the package insert and Biomet’s website . This technique was prepared in conjunction with a licensed health care professional . Biomet does not practice medicine and does not recommend any particular orthopedic implant or surgical technique for use on a specific patient . The surgeon is responsible for determining the appropriate device(s) and technique(s) for each individual patient . Not for distribution in France . Legal Manufacturer Authorised Representative Biomet Trauma Biomet UK Ltd . 0086 56 East Bell Drive Waterton Industrial Estate P .O . Box 587 Bridgend, South Wales Warsaw, Indiana 46581 CF31 3XA USA UK ©2014 Biomet Trauma • Form No . BMET0400 1-GBLA4. • REV1014 www.biomet.com.
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