BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2972860 · Received February 21, 2013

    Report

    Report Number
    1030489-2013-00590
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT, CONSISTENT WITH TORSIONAL OVERLOAD, WITH THE TIP JUST BELOW THE FRACTURE SURFACES PLASTICALLY DEFORMED. ADDITIONALLY, THE ASSEMBLY ATTACHMENT PIN TO THE INTERNAL BUSHING HAS BEEN BROKEN, CONSISTENT WITH TORSIONAL OVERLOAD CONDITION. DIMENSIONAL INSPECTION OF THE INNER SHAFT DIAMETER, AS WELL AS THE ASSOCIATED MATERIAL HARDNESS CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE. IT WAS REPORTED THAT THE DRIVER TIP BROKE DURING BONE SCREW INSERTION AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75573 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA RS11C038

    Patients

    Seq Age Sex Outcome Treatment
    1