BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC DRILL BIT

    MDR report key: 23318 · Received July 11, 1995

    Report

    Report Number
    MW1006460
    Event Type
    Malfunction
    Date Received
    July 11, 1995
    Date of Event
    June 21, 1995
    Report Date
    June 27, 1995
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORTHOPEDIC SURGEON, WORKING ON FRACTURE, USING AN ORTHOPEDIC DRILL AND BIT. DRILL BIT SHEARED WHILE SURGEON DRILLING. SURGEON WAS ABLE TO RETRIEVE SHEARED PORTION OF THE BIT FROM THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC DRILL BIT DRILL BIT HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO