BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.8 FLEXIBLE DRILL BIT

    MDR report key: 1100604 · Received August 5, 2008

    Report

    Report Number
    MW5007905
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 5, 2008
    Manufacturer
    DEPUY
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 6.5 MM CANCELLOUS SCREW WAS BEING PREDRILLED THROUGH THE CUP AND THE DRILL BROKE. THE DRILL BIT WAS RETAINED IN THE ILIUM BENEATH THE SURFACE. THE DRILL BIT WAS PALPATED WITH THE DEPTH GAUGE AND NOTED TO BE COUNTER-SUNK. BROKEN OFF PIECE WAS NOT RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.8 FLEXIBLE DRILL BIT FLEXIBLE DRILL BIT HTW DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR