BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4173197 · Received September 30, 2014

    Report

    Report Number
    4173197
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    January 6, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BIOMET
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    PIECE OF EQUIPMENT (T-HANDLE STARTER AWL FROM BIOMET LOANER TOTAL KNEE INSTRUMENT TRAY SET) BROKE DURING TOTAL KNEE ARTHROPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607493 * PROSTHESIS, KNEE JWH BIOMET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *