BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TWIST DRILL/2 X 70 MM, STRYKER

    MDR report key: 117804 · Received September 4, 1997

    Report

    Report Number
    8010177-1997-00045
    Event Type
    Injury
    Date Received
    September 4, 1997
    Date of Event
    July 23, 1997
    Report Date
    September 3, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY EVALUATION: EVALUATION OF THIS EVENT CANNOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED TO HOWMEDICA LEIBINGER GMBH. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    ONE TWIST DRILL HAD A "WOBBLE" WHEN TESTED IN AIR. THE SECOND TWIST DRILL BROKE WHEN TESTED. THIS EVENT DID NOT RESULT IN ANY ADVERSE CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL/2 X 70 MM, STRYKER INSTRUMENT HTW HOWMEDICA INC. NA NA QTY.2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other HALL PNEUMATIC DRILL AND STRYKER COMMAND| 50 ELECTRIC DRILL.