BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTA FCX STEP DRILL

    MDR report key: 123675 · Received September 29, 1997

    Report

    Report Number
    2219689-1997-00489
    Event Type
    Injury
    Date Received
    September 29, 1997
    Date of Event
    August 22, 1997
    Report Date
    September 26, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HTW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METALLURGICAL ANALYSIS RESULTS SUGGEST THAT THIS EVENT WOULD NOT BE ASSOCIATED WITH THE DEVICE BUT RATHER WOULD BE ATTRIBUTED TO USER TECHNIQUE. THE DEVICE WAS SUBJECTED TO EXCESSIVE NON AXIAL FORCES CAUSING MAXIMUM STRESS ON THE DISTAL END OF THE DRILL WHICH RESULTED IN THE DRILL BREAKING AT THE JUNCTION OF THE DRILL STEP.

    Description of Event or Problem · 1

    THE TIP OF THE STEP DRILL BROKE AND BECAME LODGED IN PT'S FEMORAL HEAD. THE SURGEON WAS UNABLE TO RECOVER THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTA FCX STEP DRILL Implant INSTRUMENT HTW HOWMEDICA INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other