BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3781528 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02351
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUALLY AND DIMENSIONALLY CONFIRMED THE INSTRUMENT IS BROKEN AT THE BASE OF THE RADIUS NEAR THE 50MM 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, AND RIVER LINES SUGGESTING THE DIRECTION OF PROPAGATION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-ILIAC. IT WAS REPORTED THAT THE TAP SHEARED OFF IN THE ILIAC DURING USE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260001 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT TAP, BONE HWX MSD BARTLETT MFG NA BA05A013

    Patients

    Seq Age Sex Outcome Treatment
    1