BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8064233 · Received November 13, 2018

    Report

    Report Number
    0001526350-2018-00513
    Event Type
    Malfunction
    Date Received
    November 13, 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
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). (B)(4). FOREIGN: (B)(6). SKIN GRAFT MESHER DEVICE, SERIAL NUMBER (B)(4), FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 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 19, 2017 REVEALED THAT THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), DOES NOT CUT PROPERLY AND MUST BE REPLACED. THE ROLLER END WAS DAMAGED AND THERE WERE SEVERAL SHARP POINTS ON THE SHAFT. THE ROLLER AND THE BEARING WASHER WERE DAMAGED AND WORN. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY MEDICREA ON (B)(6) 2017 WHICH INCLUDED REPLACEMENT OF THE BOTTOM ROLLER 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 ROLLER END WAS DAMAGED AND THERE WERE SEVERAL SHARP POINTS ON THE SHAFT. 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 ROLLER END WAS DAMAGED AND THERE WERE SEVERAL SHARP POINTS ON THE SHAFT. 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 DAMAGED PRODUCT AND IS NOT CUTTING. THERE IS A SHARP POINT ON SHAFT WHERE HANDLE GOES, ROLLER DAMAGE. PRODUCT RECEIVED WITH THE CUTTER SIZE 1,5 THIS CUTTER DOESN'T CUT PROPERLY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903126 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63430592

    Patients

    Seq Age Sex Outcome Treatment
    1