BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 475526 · Received July 30, 2003

    Report

    Report Number
    MW1029149
    Event Type
    Malfunction
    Date Received
    July 30, 2003
    Date of Event
    June 16, 2003
    Report Date
    July 30, 2003
    Manufacturer
    BIOMET INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM THE MFR 9/9/03: CO'S REVIEW OF THIS INCIDENT DETERMINED THAT THIS WAS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    DRILL BIT BROKE OFF IN PT'S LEG. ALL PIECES REMOVED. X-RAY TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET DRILL BIT HTW BIOMET INC. 3.2 MM 551860 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR