BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRASSELER LARGE BONE BLADE

    MDR report key: 16618200 · Received March 24, 2023

    Report

    Report Number
    MW5115967
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 15, 2023
    Report Date
    March 22, 2023
    Manufacturer
    BRASSELER U.S.A. MEDICAL, LLC
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLADE BROKE WHILE MAKING FEMORAL CUTS IN A TOTAL KNEE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584230 BRASSELER LARGE BONE BLADE BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL GFA BRASSELER U.S.A. MEDICAL, LLC NW5J8

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male