BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 4908261 · Received July 9, 2015

    Report

    Report Number
    1526350-2015-00118
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 12, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS MANUFACTURED ON 06/24/2009, AND WAS PREVIOUSLY REPAIRED (B)(6) 2011 FOR A NON-RELATED ISSUE. A ZIMMER SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), WAS NOT RETURNED TO ZIMMER (B)(6) FOR EVALUATION. THE CUSTOMER DID NOT RETURN ANY CUTTERS FOR EVALUATION. INVESTIGATION REVEALED THE COMB WAS BENT AND THE TEST CUTTER WAS UNABLE TO BE INSERTED. THE RATCHET WAS NOT RATCHETING AND WAS JAMMED. THERE WAS WEAR TO THE SHOULDER BOLTS, WASHERS AND NUTS. PRIOR TO REPAIR, THE TEST MESH WAS NOT PERFORMED DUE TO THE BENT COMB. REPAIR OF THE DEVICE INCLUDED REPLACEMENT OF THE COMB, SHOULDER BOLTS, WASHERS, NUTS AND THE DISASSEMBLY AND LUBRICATION OF THE RATCHET ASSEMBLY. THE REPORTED EVENT WAS MOST LIKELY DUE TO THE DAMAGED COMB, WHICH WAS MOST LIKELY DUE TO IMPROPER HANDLING BY THE USER. THE DEVICE WAS REPAIRED AND SCHEDULED TO BE RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT WHILE USING THE INDENTATION WHERE THE BLADE SITS, A BEND WAS OBSERVED DURING THE USE OF THE MESHER. THE SKIN WAS INSERTED AND THE SKIN WAS STICKING AND BUNCHING TOGETHER WHICH LED TO A PART OF THE HARVEST BEING UNUSABLE. THERE WAS NO DELAY TO THE PROCEDURE AND NO ALTERNATE DEVICE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445367 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1