BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2990046 · Received March 5, 2013

    Report

    Report Number
    1030489-2013-00668
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY AND DIMENSIONALLY CONFIRMED THE INSTRUMENT IS BROKEN AT THE BASE OF THE RADIUS NEAR THE 65MM MARK. NO SURFACE DEFECT IDENTIFIED THAT COULD CONTRIBUTE TO CRACK PROPAGATION. DIMENSIONAL INSPECTION OF THE RELEVANT DIMENSIONS, AS WELL AS THE INSTRUMENT HARDNESS WERE INSPECTED AND FOUND TO BE WITHIN PRINT SPECIFICATION. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE FINDS A FAIRLY BRITTLE FRACTURE WITH NO INDICATION OF TORSION OR FATIGUE, WITH RIVERLINES AND SHEAR LIPS, CONSISTENT WITH BEND STRESS OVERLOAD. THE LOCATION AND FRACTOGRAPHIC EVIDENCE OF THE FRACTURE SURFACE, IN CONJUNCTION WITH VERIFICATION OF CONFORMANCE TO THE RELEVANT DIMENSIONAL AND MATERIAL SPECIFICATIONS SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TAP BROKE DURING USE IN THE PATIENT. THE TAP WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93963 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT TAP, BONE HWX MSD BARTLETT MFG NA BA05A015

    Patients

    Seq Age Sex Outcome Treatment
    1