BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESHGRAFT II INSTRUMENT ONLY

    MDR report key: 8150800 · Received December 11, 2018

    Report

    Report Number
    0001526350-2018-01090
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 10, 2018
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). FOREIGN - (B)(6). CONCLUSION SUMMARY: ON NOVEMBER 14, 2018, IT WAS REPORTED THAT THE MESHGRAFT SYSTEM IS CUTTING UNILATERAL. THE CUSTOMER RETURNED A MESHGRAFT II DEVICE, 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 MESHGRAFT II SERIAL NUMBER (B)(4) AS DOCUMENTED IN THE VDOC SERVICE PORTAL. PRODUCT REVIEW OF THE MESHGRAFT II BY MEDICREA ON NOVEMBER 30, 2018 REVEALED THAT THE DEVICE IS IN GOOD CONDITION, BUT THE CUTTER IS NOT COMPLETELY AS SHARP AS IT SHOULD BE TO PRODUCE A GOOD GRAFT. THE DEVICE WAS ALSO OUTSIDE CALIBRATION SPECIFICATIONS. REPAIR OF THE MESHGRAFT II WAS PERFORMED BY MEDICREA ON NOVEMBER 30, 2018 WHICH INCLUDED RECALIBRATION OF THE DEVICE. MESHGRAFT II, 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 DEVICE WAS IN GOOD CONDITION, BUT THE CUTTER WAS NOT COMPLETELY AS SHARP AS IT SHOULD BE TO PRODUCE A GOOD GRAFT. THE ISSUE WAS RESOLVED BY CALIBRATING THE SYSTEM. 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 DEVICE WAS IN GOOD CONDITION, BUT THE CUTTER WAS NOT COMPLETELY AS SHARP AS IT SHOULD BE TO PRODUCE A GOOD GRAFT. THE ISSUE WAS RESOLVED BY CALIBRATING THE SYSTEM. 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 IS CUTTING UNILATERAL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992436 MESHGRAFT II INSTRUMENT ONLY EXPANDER, SURGICAL, SKIN GRAFT FZW ZIMMER SURGICAL, INC. 63898119

    Patients

    Seq Age Sex Outcome Treatment
    1