BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2011530 · Received March 9, 2011

    Report

    Report Number
    1030489-2011-00258
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS RETURNED FOR EVALUATION. VISUALLY CONFIRMED INSTRUMENT BROKEN AT ~70MM MARK. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE REVEALED FAIRLY BRITTLE FRACTURE WITH NO INDICATION OF FATIGUE OR TORSION. RIVER LINES SUGGEST THE LOCATION AND DIRECTION OF FRACTURE INITIATION AND PROPAGATION. THE LOCATION AND NATURE OF FRACTURE SURFACE SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TAP BROKE WHILE IN USE ON THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT TAP, BONE HWX MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA BA03K020

    Patients

    Seq Age Sex Outcome Treatment
    1