BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1952854 · Received January 7, 2011

    Report

    Report Number
    1030489-2011-00017
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MICROPITUITARY SUPERIOR SHAFT TIP IS BROKEN OFF AT THE CENTER OF THE JAW PIVOT PIN FORWARD. THE BROKEN OFF PORTION OF THE SHAFT IS MISSING AND NOT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION REVEALS A FAIRLY BRITTLE FRACTURE SURFACE. 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. 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 BROKE AND WOULD NOT CLOSE. ALTHOUGH THE INSTRUMENT WAS USED INTRAOPERATIVELY, 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 GZ06H009

    Patients

    Seq Age Sex Outcome Treatment
    1