BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2132772 · Received June 17, 2011

    Report

    Report Number
    1030489-2011-00759
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. PROBE BENT IN MULTIPLE LOCATIONS STARTING ~55 MM FROM THE END OF THE TIP, WITH APPROXIMATELY 21 MM OF THE TIP MISSING AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF FRACTURE REVEALED A QUASI-BRITTLE FRACTURE SURFACE WITH NO VISIBLE INDICATIONS OF FATIGUE. THE BENT TIP, NATURE AND LOCATION OF FRACTURE THE SURFACE SUGGESTS FAILURE DUE TO BEND STRESS OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE FEELER BROKE AT THE DISTAL TIP. ALL PIECES WERE RETRIEVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA 373441

    Patients

    Seq Age Sex Outcome Treatment
    1