BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8059821 · Received November 12, 2018

    Report

    Report Number
    0001526350-2018-00510
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Report Date
    May 30, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CONCLUSION SUMMARY: ON APRIL 18, 2017, IT WAS REPORTED THAT THE DEVICE REQUIRED A TECHNICAL REVIEW. THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION, CHANGE NOTICES OR ANY OTHER ISSUES WITH MANUFACTURING OR WITH THE DEVICE. THE DHR REVIEW ALSO FOUND THAT ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. MEDICREA HAS NOT PREVIOUSLY REPAIRED/EVALUATED SKIN GRAFT MESHER SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE SKIN GRAFT MESHER BY MEDICREA ON MAY 2, 2017 REVEALED THAT THE SIDE PLATES, CARRIER GUIDE BLOCK AND COMB WERE WORN AND DAMAGED. THE SERVICE TECHNICIAN NOTED THAT THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), IS BEGINNING TO BECOME WORN AND FAILED TO PRODUCE AN ACCEPTABLE MESH. THE CUSTOMER SHOULD PLAN TO REPLACE THIS CUTTER. THE OVERALL SAMPLE MESH PRODUCED BY THE DEVICE WAS NOT ACCEPTABLE. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY MEDICREA ON MAY 29, 2017 WHICH INCLUDED REPLACEMENT OF THE SIDE PLATES, CARRIER GUIDE BLOCK, COMB AND BEARING WASHER. SKIN GRAFT MESHER, SERIAL NUMBER (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE SIDE PLATES, CARRIER GUIDE BLOCK AND COMB WERE WORN AND DAMAGED. THE 1.5:1 RATIO CUTTER WAS BEGINNING TO BECOME WORN AND FAILED TO PRODUCE AN ACCEPTABLE MESH. THE OVERALL SAMPLE MESH PRODUCED BY THE DEVICE WAS NOT ACCEPTABLE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED WITH THE INFORMATION THAT WAS PROVIDED. DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE SIDE PLATES, CARRIER GUIDE BLOCK AND COMB WERE WORN AND DAMAGED. THE 1.5:1 RATIO CUTTER WAS BEGINNING TO BECOME WORN AND FAILED TO PRODUCE AN ACCEPTABLE MESH. THE OVERALL SAMPLE MESH PRODUCED BY THE DEVICE WAS NOT ACCEPTABLE. IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SIDE PLATE, CARRIER AND Z SKIN COMB ARE USED AND DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899894 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63037204

    Patients

    Seq Age Sex Outcome Treatment
    1