BEUDAMED
    FDA Adverse Event Other Summary report: N

    3.2 QUICK COUPLING DRILL BIT

    MDR report key: 21769 · Received May 11, 1995

    Report

    Report Number
    MW1005907
    Event Type
    Other
    Date Received
    May 11, 1995
    Date of Event
    April 16, 1995
    Report Date
    April 27, 1995
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING AN ORTHOPEDIC SURGERY, SURGEON WAS DRILLING INTO THE BONE WITH A 3.2 DRILL BIT. THE DRILL BIT BROKE OFF IN THE PT'S TIBIA. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.2 QUICK COUPLING DRILL BIT HTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other