BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1951682 · Received January 6, 2011

    Report

    Report Number
    1030489-2011-00016
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND OPTICAL EXAMINATION CONFIRMS THE TIP HAS BEEN BROKEN OFF, APPROXIMATELY 1MM ABOVE SCREW DRIVER TIP, AND 5MM ABOVE MULTIPLE AXLE SCREW INTERFACE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT, BRITTLE FRACTURE SURFACE WITH CIRCULAR MATERIAL FLOW AND PLASTIC DEFORMATION AT TIP INTERFACE, CONSISTENT WITH TORSIONAL OVERLOAD. ADDITIONALLY, THE LOCATION OF FAILURE SUGGESTS POSSIBLE BREAKAGE AT WELDED UNION.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF SUBMITTED PICTURES CONFIRM SCREWDRIVER TIP BROKEN OFF OF SHAFT. EXAMINATION OF THE FRACTURE SURFACE (FROM SUBMITTED PICTURES) APPEARS TO SHOW A FAIRLY FLAT FRACTURE SURFACE, WITH CIRCULAR MATERIAL MOVEMENT INDICATIVE OF TORSIONAL OVERLOAD. DEVICE HISTORY RECORDS 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 SCREW DRIVER BROKE WHEN IMPLANTING THE SCREW. THERE WAS NO BROKEN PIECE REMAINING IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA IT05K010

    Patients

    Seq Age Sex Outcome Treatment
    1