BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNTHES 25MM DRILL BIT

    MDR report key: 47436 · Received November 4, 1996

    Report

    Report Number
    1719045-1996-00008
    Event Type
    Other
    Date Received
    November 4, 1996
    Date of Event
    July 27, 1996
    Report Date
    November 4, 1996
    Manufacturer
    SYNTHES USA
    Product Code
    HTW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS DRILLING FOR PLACEMENT OF SCREW IN THE MEDIAL TIBIA OF A FRACTURED RIGHT ANKLE WHEN THE DRILL BIT BROKE, AND BECAME EMBEDDED IN THE TIBIA WHERE IT REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES 25MM DRILL BIT DRILL BIT HTW SYNTHES USA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other