BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2000880 · Received February 24, 2011

    Report

    Report Number
    1030489-2011-00195
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    March 16, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED INSTRUMENT BROKEN AT ~70MM MARK, WITH A ~20MM PORTION OF THE SHAFT MISSING AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALED FAIRLY BRITTLE FRACTURE WITH NO INDICATION OF FATIGUE OR TORSION. RIVER LINES SUGGEST DIRECTION OF FRACTURE. THE LOCATION AND NATURE OF FRACTURE SURFACE SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT L4-S1. IT WAS REPORTED THAT THE TAP BROKE INTO THREE PIECES WHILE IN USE IN THE PEDICLE. THE PIECES WERE RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT TAP, BONE HWX WARSAW ORTHOPEDIC, INC NA BA04H006

    Patients

    Seq Age Sex Outcome Treatment
    1