BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL BIT

    MDR report key: 1160944 · Received September 12, 2008

    Report

    Report Number
    MW5008303
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 12, 2008
    Manufacturer
    STRYKER ORTHOPEDICS
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC SURGICAL PROCEDURE, THE DRILL BIT BROKE OFF IN THE SCREW HOLE AND THE MD WAS UNABLE TO REMOVE THE SMALL BROKEN PIECE. HE LEFT THE PIECE IN THE HOLE OF THE BONE. HE STATED IT WOULD HAVE CAUSED MORE DAMAGE IN TRYING TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRILL BIT DRILL BIT - 3.5 X 130 MM DRILL BIT HTW STRYKER ORTHOPEDICS K801348

    Patients

    Seq Age Sex Outcome Treatment
    1