BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1841900 · Received September 17, 2010

    Report

    Report Number
    1030489-2010-01246
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORDS WERE REVIEWED - NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THE SUPERIOR SHAFT IS BROKEN OFF FROM THE CENTERLINE OF THE JAW PIVOT PIN FORWARD. THE BROKEN OFF PORTION OF THE SHAFT IS MISSING AND NOT RETURNED FOR ANALYSIS. OPTICAL EXAMINATION OF FRACTURE SURFACE DISCOVERED A FAIRLY BRITTLE FRACTURE, WITH NO INDICATION OF FATIGUE. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFTS ARE CONSISTENT WITH APPLICATION OF EXCESSIVE FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BROKEN DURING USE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PITUITARY LXH MEDTRONIC SOFAMOR DANEK NA GZ07C024

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK