BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17442763 · Received August 2, 2023

    Report

    Report Number
    0001526350-2023-00834
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    December 16, 2022
    Report Date
    August 2, 2023
    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
    UK
    Reporter Occupation
    003

    Narratives

    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. THE CUTTER APPEARED TO HAVE EVEN SIGNS OF WEAR THROUGHOUT CUTTER CONSISTENT WITH INTENDED USE. CUTTERS CANNOT BE FULLY REPAIRED WITHOUT REPLACEMENT; THEREFORE, IT WAS RETURNED TO THE CUSTOMER 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. E1 TELEPHONE NUMBER: (B)(6). COUNTRY: UNITED KINGDOM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001526350-2023-00322-1 0001526350-2023-00836 0001526350-2023-00838 0001526350-2023-00840.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DEMONSTRATION, THE DEVICE SEEMED TOO TOUGH TO USE AND WAS TEARING THE DONOR SKIN. THERE WAS NOTHING NOTICEABLY BROKEN ON THE MESHER AND IT SEEMED TO BE ASSEMBLED CORRECTLY BUT IT WAS TEARING THE SKIN AS IT WAS PUT THROUGH THE MESHER ON THE CARRIER. DURING PRODUCT EVALUATION, THE CUTTER FAILED THE TEST CUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695373 Z.S.G.M. CUTTER 1.5:1 RATIO ( CAUTION: SHARP ) SKIN GRAFT MESHER FZW ZIMMER SURGICAL, INC. N/A 64581482 00889024375444

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose