BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1790336 · Received August 5, 2010

    Report

    Report Number
    1030489-2010-01020
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PROBE WAS RETURNED FOR EVALUATION. PROBE BENT IN MULTIPLE LOCATIONS FROM APPROX 80 MM TO END OF TIP, WITH APPROXIMATELY 35MM OF TIP MISSING AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF FRACTURE REVEALED A QUASI-BRITTLE FRACTURE SURFACE WITH NO VISIBLE INDICATIONS OF FATIGUE. THE BEND TIP, NATURE AND LOCATION OF FRACTURE, THE SURFACE SUGGESTS FAILURE DUE TO BEND STRESS OVERLOAD. 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 PT UNDERWENT A SPINAL PROCEDURE. DURING THE SURGERY, THE PROBE BROKE WHILE BEING USED TO TREAT THE PT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PROBE LXH MEDTRONIC SOFAMOR DANEK NA SA08F038

    Patients

    Seq Age Sex Outcome Treatment
    1