BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE DRILL BIT

    MDR report key: 1010523 · Received February 5, 2008

    Report

    Report Number
    1010523
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 11, 2008
    Report Date
    February 4, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A TOTAL HIP REVISION, TWO BIOMET DISPOSABLE DRILL BITS BROKE WHILE IN USE. STAFF RETRIEVED THE BROKEN PIECES AND SO THERE WERE NO RETAINED PIECES LEFT IN THE PATIENT. NO ADVERSE OUTCOME TO PATIENT. THE BROKEN DRILL BITS WERE TURNED OVER TO THE COMPANY'S SALES REPRESENTATIVE. OUR HOSPITAL SWITCHED TO ONLY USING DISPOSABLE DRILL BITS AFTER EXPERIENCING NUMEROUS DRILL BIT BREAKAGE OCCURRENCES WITH THE RE-USEABLE DRILL BITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE DRILL BIT DRILL BIT, SURGICAL HTW BIOMET, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR