BEUDAMED
    FDA Adverse Event Other Summary report: N

    TAP INSTRUMENT

    MDR report key: 5996128 · Received September 30, 2016

    Report

    Report Number
    MW5065137
    Event Type
    Other
    Date Received
    September 30, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 30, 2016
    Manufacturer
    STRYKER GLOBAL HEADQUARTERS
    Product Code
    LXH
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    SURGEONS WERE USING TAP INSTRUMENT FROM STRYKER LAG SCREW TRAY #2. UPON PLACING TAP IN DRILL SITE WITHIN BONE, TAP SNAPPED/BROKE OFF IN PATIENT'S MANDIBLE BONE. SURGEONS HAD TO DRILL THE BROKEN INSTRUMENTATION LOOSE FROM PATIENT'S BONE IN ORDER TO PROCEED WITH SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640872 TAP INSTRUMENT STRYKER TAP INSTRUMENT LXH STRYKER GLOBAL HEADQUARTERS 6020501

    Patients

    Seq Age Sex Outcome Treatment
    1