BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 8103702 · Received November 26, 2018

    Report

    Report Number
    0001526350-2018-00512
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Report Date
    November 26, 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
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4).. (B)(4). CONCLUSION SUMMARY: ON (B)(6) 2017, IT WAS REPORTED THAT THE DEVICE DOES NOT EVENLY CUT THE GRAFT OVER ITS ENTIRE WIDTH WITH THE 3:1 AND 1.5:1 RATIO CUTTER. 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), A 3:1 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 (B)(4) 2017 REVEALED THAT THE TWO CUTTERS THAT WERE RETURNED WERE IN GOOD CONDITION. THE SAMPLE MESHES WITH THE CUTTERS WERE ACCEPTABLE BUT THE END OF THE AXIS OF THE CUTTER WAS DAMAGED. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY MEDICREA ON (B)(4) 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 NON-VERIFIABLE SINCE DURING THE PRODUCT REVIEW BY MEDICREA IT WAS NOTED THAT THE TWO CUTTERS THAT WERE RETURNED WERE IN GOOD CONDITION. THE SAMPLE MESHES WITH THE CUTTERS WERE ACCEPTABLE BUT THE END OF THE AXIS OF THE CUTTER WAS DAMAGED. 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 TWO CUTTERS THAT WERE RETURNED WERE IN GOOD CONDITION. THE SAMPLE MESHES WITH THE CUTTERS WERE ACCEPTABLE BUT THE END OF THE AXIS OF THE CUTTER WAS DAMAGED. 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. EXTERNAL CONTRACTOR

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS A DAMAGED PRODUCT AND IT WAS NOT CUTTING. DEVICE WAS NOT CUTTING AND THE MESHER DOES NOT WORK PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944269 ZIMMER SKIN GRAFT MESHER EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. N/A 63278397

    Patients

    Seq Age Sex Outcome Treatment
    1