BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3012527 · Received March 20, 2013

    Report

    Report Number
    1030489-2013-00784
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. MACROSCOPIC EXAMINATION CONFIRMS DRIVER TIP HAS BEEN BROKEN OFF, AND NOT RETURNED FOR ANALYSIS. A PORTION OF THE FIRST MAS HEAD THREAD IS BROKEN OFF. THIS SUGGESTS THE MAS MAY NOT HAVE BEEN FULLY ENGAGED INTO THE INSTRUMENT MAS HEAD THREAD, WHICH WOULD TEND TO MITIGATE BENDING STRESSES ON THE INNER SHAFT. MICROSCOPIC EXAMINATION OF FRACTURE SURFACE IDENTIFIED A QUASI-BRITTLE FRACTURE THAT APPEARS TO HAVE INITIATED AT THE BASE OF THE HEX, WITH RIVER LINES, SHEAR LIP, AND NO INDICATION OF FATIGUE OR TORSIONAL OVERLOAD. THE LOCATION AND ANGLE OF THE FRACTURE, SURFACE MORPHOLOGY, NATURE OF THE THREAD DAMAGE, AND THE ABSENCE OF EVIDENCE OF TORSION SUGGEST FAILURE DUE TO BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115131 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC NA PR10G002

    Patients

    Seq Age Sex Outcome Treatment
    1