BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP )

    MDR report key: 16303510 · Received February 6, 2023

    Report

    Report Number
    0001526350-2023-00137
    Event Type
    Malfunction
    Date Received
    February 6, 2023
    Report Date
    May 1, 2023
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375468
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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. ASSOCIATED MESHER MEDWATCH: 0001526350-2023-00138.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS FOUND TO PRODUCE AN INCOMPLETE CUT DURING THE MESH TEST CUT; HOWEVER, THE REPAIR WAS NOT COMPLETED BECAUSE THE CUTTER WAS RETURNED TO THE CUSTOMER WITH NOTIFICATION THAT THE DEVICE FAILED THE MESH TEST CUT ACCEPTANCE CRITERIA. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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: 0001526350-2023-00138-1; 0001526350-2023-00136-1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MAINTENANCE, THE CUTTER FAILED THE TEST CUT ACCEPTANCE WITH AN INCOMPLETE CUT. NO ADVERSE EVENTS ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    THERE ARE NO ADDITIONAL DETAILS REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114708 Z.S.G.M. CUTTER 3:1 RATIO ( CAUTION: SHARP ) SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 63924161 00889024375468

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown