BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 1392794 · Received May 19, 2009

    Report

    Report Number
    MW5011186
    Event Type
    Malfunction
    Date Received
    May 19, 2009
    Date of Event
    April 20, 2009
    Report Date
    May 19, 2009
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ORTHOPEDIC PROCEDURE, DRILL BIT BROKE OFF IN PT'S FEMUR. ORTHOPEDIC SURGEON UNABLE TO REMOVE IT. DRILL BIT LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET DRILL BIT, 3.2 MM HTW

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR