BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 16522609 · Received March 10, 2023

    Report

    Report Number
    0001526350-2023-00264
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Report Date
    August 9, 2023
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE DEVICE HAD A DAMAGED GEAR AND WAS OUT OF CALIBRATION. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00262-1; 0001526350-2023-00263-1.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER. MEDWATCH REPORTS FOR ASSOCIATED CUTTERS: 0001526350 -2023 -00262; 0001526350 -2023 -00263.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE MADE AN INCOMPLETE MESH. NO ADVERSE EVENT IS ASSOCIATED WITH THIS MALFUNCTION. NO HARM OR DELAY WAS REPORTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435654 ZIMMER SKIN GRAFT MESHER SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 63138572

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose