BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1841903 · Received September 17, 2010

    Report

    Report Number
    1030489-2010-01243
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INFERIOR SHAFT IS CRACKED AND BENT TO ONE SIDE AT THE CENTERLINE OF THE JAW PIVOT PIN, CONSISTENT WITH BEND STRESS OVERLOADING. THE LOCATION, DIRECTION, AND AMOUNT OF FORCE REQUIRED IN ORDER INDUCE FRACTURE OF THE SHAFT CONSISTENT WITH BEND STRESS OVERLOADING RESULTING IN THE FOREGOING EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT WAS BENT/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 GZ07D052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK