SURGICAL TECHNIQUE
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TABLE OF CONTENTS System Overview Indications... 4 System Features... 4 Surgical Technique Surgical Approach & Exposure... 5 Prepare the Joint... 5 Insert Bone Graft... 5 Select & Contour Plate......................................................... 6 Insert Distal 2.7mm Screws... 7 Insert Proximal 3.5mm Screws... 7 Closure... 8 Optional Implant Removal... 8 Product Information Wrist Fusion Plates... 10 Screws & Instrumentation... 11 3
SYSTEM OVERVIEW INDICATIONS The OrthoPediatrics is indicated for wrist arthrodesis and fractures of other small bones in children, adolescents, and small stature adults. Specific indications include: Posttraumatic arthrosis of the joints of the wrist. Rheumatoid wrist deformities requiring restoration. Complex carpal instability. Postseptic arthritis of the wrist. Severe unremitting wrist pain related to motion. Brachial plexus nerve palsies. Tumor resection. Spastic deformities. SYSTEM FEATURES The OrthoPediatrics Wrist Fusion Plate System consists of two implant length offerings, to fit patients both with and without a proximal row carpectomy (PRC). Bending templates are included in the set to assist with intra-operative contouring of the plate into either dorsiflexion or palmar flexion. The plates are manufactured from stainless steel and are designed to be low profile to prevent soft tissue irritation and to minimize plate prominence. The Wrist Fusion Plates accept 2.7mm screws both distally and in the capitate, and 3.5mm screws proximally (See Figure 1). The plates are compatible with the screws and associated instrumentation in the 2.7/3.5 PediFrag System. Screw families include: 00-1005-25XX, 00-1005-26XX, 00-0903-25XX, and 00-0903-26XX. 99mm Plate Proximal Holes 3.5mm, Locking, Compression Capitate Hole 2.7mm, Distal Holes 2.7mm, Locking 112mm Plate FIGURE 1 Proximal Holes 3.5mm, Locking, Compression Capitate Hole 2.7mm, Distal Holes 2.7mm, Locking 4
SURGICAL TECHNIQUE SURGICAL APPROACH & EXPOSURE Position the patient supine. Create a longitudinal incision, and expose the dorsal aspect of the third metacarpal, as well as the dorsal aspect of the distal radius. PREPARE THE JOINT Prepare the joints to be fused this includes exposure and decortication of the scaphocapitate joint, capitolunate joint, radioscaphoid joint, and radiolunate joint. In certain cases, additional joints to be fused include the ulnar midcarpal joint, lunotriquetral joint, second carpometacarpal joint, and third carpometacarpal joint (See Figure 2). INSERT BONE GRAFT If there is a bone void that may prevent reduction or bone healing, allograft, autograft, or synthetic graft can be used. Autograft is commonly harvested from the radius, olecranon, or iliac crest. If a proximal row carpectomy is performed, autograft can be harvested from the proximal row. Bones to fuse Commonly fused FIGURE 2 Optional fusion 5
SURGICAL TECHNIQUE SELECT & CONTOUR PLATE The wrist fusion plate bending templates can aid in determining the appropriate length of implant to be used, and contour required for the final implant, by placing both options over the joint fusion area and determining which length will provide the best fixation with contour applied. The holes and slots in the bending template match the location of locking holes and compression holes on the final implant, respectively. Bending templates can be contoured by hand (See Figure 3). Once the appropriate bending template is selected and the contour is applied, the corresponding implant is selected and the contour is applied to it with bending irons (included in the 2.7/3.5 PediFrag System) or a tabletop bender. Note: Bending templates and implants are marked with their length to aid in size selection. Translation of template contour to final implant will ensure proper fit. Precaution: Avoid placing screw holes over joints or osteotomies to aid in fixation. Warning: Implantation of the bending template can lead to revision; bending templates are marked Do Not Implant FIGURE 3 6
SURGICAL TECHNIQUE Place the distal end of the plate directly over the dorsal aspect of the third metacarpal (See Figure 4). Insert 2.7mm PediFrag screws (locking or non-locking) into the distal holes and capitate hole per the 2.7mm/3.5mm PediFrag System Surgical Technique (ST-1005-01-00). INSERT PROXIMAL 3.5mm SCREWS Place the proximal end of the plate directly over the dorsal aspect of distal radius. Insert 3.5mm PediFrag screws (locking or non-locking) into the proximal holes per the 2.7mm/3.5mm PediFrag System Surgical Technique (ST-1005-01-00). Note: Incorrect screw size selection can lead to the screw not seating properly in the screw hole. Each end of the plate is labeled with its respective screw size. INSERT DISTAL 2.7mm SCREWS FIGURE 4 7
SURGICAL TECHNIQUE CLOSURE Close the incision in the routine fashion. Ensure soft tissues are reconstructed to minimize irritation. Apply dressing to protect the wound. OPTIONAL IMPLANT REMOVAL To remove, first unlock all locking screws from plate prior to removing all screws fully from the plate/bone. This will help avoid rotation of the plate upon removal of the final locking screw. 8
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PRODUCT INFORMATION WRIST FUSION PLATES 00-1005-6000 2.7mm/3.5mm Wrist Fusion Plate, 99mm 00-1005-6010 2.7mm/3.5mm Wrist Fusion Plate, 112mm 99mm PLATE 112mm PLATE WRIST FUSION 10
PRODUCT INFORMATION SCREWS & INSTRUMENTATION The plates are compatible with the 2.7mm and 3.5mm screws and associated instrumentation in the 2.7/3.5 PediFrag System. Screw families include: 00-1005-25XX 2.7mm Cortical Screw, T10 Hexalobe, Self Tapping 00-1005-26XX 2.7mm Locking Screw, T10 Hexalobe, Self Tapping 00-0903-25XX 3.5mm Cortical Screw, T15 Hexalobe, Self Tapping 00-0903-26XX 3.5mm Locking Screw, T15 Hexalobe, Self Tapping Additionally, included in the are the following bending templates: 01-1005-6005 2.7mm/3.5mm Wrist Fusion Bending Template, 99mm 01-1005-6010 2.7mm/3.5mm Wrist Fusion Bending Template, 112mm 2.7/3.5 PEDIFRAG 11
CAUTION: CAUTION: CAUTION: CAUTION: NOTE: Federal law restricts this device to sale by or the order of a Physician. Devices are supplied Non-Sterile. Clean and sterilize before use according to instructions. Implants components are single-use. Do not reuse. Only those instruments and implants contained within this system are recommended for use with this technique. Other instruments or implants used in combination or in place of those contained within this system is not recommended. This technique has been provided by one of our medical advisors only as guidance and it is not intended to limit the methods used by trained and experienced surgeons. This document is intended exclusively for experts in the field, i.e. physicians in particular, and expressly not for the information of laypersons. The information on the products and/or procedures contained in this document in of general nature and does not represent medical advice or recommendations. Since this information does not constitute any diagnostic or therapeutic statement with regard to any individual medical case, individual examination and advising of the respective patient are absolutely necessary and are not replaced by this document in whole or in part. The information contained in this document was gathered and compiled by medical experts and qualified OrthoPediatrics employees to the best of their knowledge. The greatest care was taken to ensure the accuracy and ease of the understanding of the information used and presented. OrthoPediatrics 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. OrthoPediatrics does not assume any liability, however, for the timeliness, accuracy, completeness or quality of the information and excludes any liability for tangible or intangible losses that may be caused by the use of this information. This document is not for distribution in France. Instructions For Use (IFU), cleaning instructions, and surgical techniques may be obtained by calling OrthoPediatrics Customer Service at 574-268-6379. Read and understand indications, warnings, and adverse effects explained in IFU's prior to use. OrthoPediatrics, ArmorLink, Jiminy, PediFlex, PediFrag, PediLoc, PediNail, PediPlates, PLEO, RESPONSE, Scwire, ShieldLoc, TorqLoc, and the OP and Pedi logos are trademarks of OrthoPediatrics Corp. OrthoPediatrics is a registered trademark in Brazil, S.Korea, and the U.S.A. Jiminy is a registered trademark in the European Union and the U.S.A. PediLoc and PediPlates are registered trademarks in Chile and the U.S.A. The OP logo is a registered trademark in Colombia, European Union, Japan, and the U.S.A. The Pedi logo is a registered trademark in Argentina, Australia, Brazil, Chile, Colombia, European Union, Israel, Mexico, New Zealand, S.Korea, Taiwan, Turkey, and the U.S.A. Scwire is a registered trademark in the U.S.A. 2850 Frontier Drive, Warsaw, IN 46582 ph: 574.268.6379 or 877.268.6339 fax: 574.268.6302 www.orthopediatrics.com OrthoPediatrics Corp. 2017 ST-1005-02-00 Rev A