BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2173480 · Received July 23, 2011

    Report

    Report Number
    1030489-2011-00919
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 19, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL FLOW, CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE DURING SURGERY. THE TIP WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT APPLIANCE, FIXATION, SPINAL INTERLAMINAL LXH MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA M05J0232

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW