BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL BIT

    MDR report key: 18905 · Received January 10, 1995

    Report

    Report Number
    MW1004717
    Event Type
    Malfunction
    Date Received
    January 10, 1995
    Date of Event
    December 15, 1994
    Report Date
    December 28, 1994
    Manufacturer
    MEDICAL STERILIZATION, INC.
    Product Code
    HTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ORIF OF LEFT HIP, DISTAL TIP, 9 DRILL BIT, APPROX 3/4 INCH LONG, BROKE. DECISION MADE NOT TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT DRILL BIT HTT MEDICAL STERILIZATION, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR HALL DRILL AND REAMER #25044-01