BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP )

    MDR report key: 16183455 · Received January 17, 2023

    Report

    Report Number
    0001526350-2023-00074
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Report Date
    January 25, 2024
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FZW
    UDI-DI
    00889024375444
    PMA / PMN Number
    PREAMENDMENT
    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

    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: 0001526350-2023-00072. ASSOCIATED CUTTER: 0001526350 -2023 -00073.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE MESH. THE GEARS AND COLLARS WERE REPLACED; HOWEVER, THE CUTTER COULD NOT BE FULLY REPAIRED AND WAS RETURNED AS IS. 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: 0001526350-2023-00072-1 AND 0001526350-2023-00073-1.

    Additional Manufacturer Narrative · 0

    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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MAINTENANCE, THE CUTTER FAILED THE TEST CUT WITH AN INCOMPLETE CUT. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THIS MALFUNCTION. THE LIVING LEGACY FOUNDATION/TRANSPLANT RESC CT IS A CADAVER SKIN BANK THAT USES THE DEVICE(S) ON PREVIOUSLY RECOVERED CADAVER SKIN. THEREFORE, THERE IS NO PATIENT INVOLVEMENT AND THEREFORE NO HARM OR DELAY IN ANY SURGICAL PROCEDURE DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL DETAILS ARE AVAILABLE REGARDING THE EVENT.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819705 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 65154555 00889024375444

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown