BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/8" SCREW FIXATION BASEPLATE DRILL

    MDR report key: 1070538 · Received July 2, 2008

    Report

    Report Number
    2249697-2008-00188
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 10, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HTW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. IF DEVICE AND/OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. WAS DRILLING PILOT HOLE FOR SCREWFIX BASEPLATE WITH THE 1/8 DRILLBIT PROVIDED IN THE SET. THE DRILLBIT BROKE OFF. HE RETRIEVED THE BROKEN PIECE FROM THE PROXIMAL TIBIA WITH AN EASYOUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1/8" SCREW FIXATION BASEPLATE DRILL INSTRUMENT HTW STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other