BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 2143405 · Received June 29, 2011

    Report

    Report Number
    1030489-2011-00827
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    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 SUPERIOR SHAFT IS BROKEN OFF AT THE CENTER OF THE JAW PIVOT PIN FORWARD. THE BROKEN OFF PORTION OF THE SHAFT IS MISSING AND WAS NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION DISCOVERED A FAIRLY BRITTLE FRACTURE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT IS CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE, RESULTING IN THE FOREGOING EVENT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISUSE, RESULTING IN THE FOREGOING EVENT. 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 TIP OF THE INSTRUMENT WAS BROKEN. ALTHOUGH THE INSTRUMENT WAS USED IN SURGERY, 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 USA, INC NA GZ10J034

    Patients

    Seq Age Sex Outcome Treatment
    1