BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1587811 · Received January 15, 2010

    Report

    Report Number
    1030489-2010-00054
    Event Type
    Malfunction
    Date Received
    January 15, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 18, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE PROBE WAS RETURNED FOR EVALUATION. THE PROBE TIP BROKE OFF APPROXIMATELY 15 MM FROM THE END; THE BROKEN OFF PORTION OF THE TIP IS MISSING AND NOT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE FRACTURE REVEALED A FAIRLY TORTUOUS FRACTURE SURFACE WITH NO INDICATIONS OF FATIGUE SUGGESTING FAILURE DUE TO BEND STRESS OVERLOADING. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY APPLICABLE NONCONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SPINAL SURGERY. WHILE IN USE ON THE PATIENT, THE TIP OF THE DUAL END PROBE BROKE OFF. THE TIP WAS RETRIEVED IMMEDIATELY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT PROBE HXB MEDTRONIC SOFAMOR DANEK MANUFACTURING NA PT04A004

    Patients

    Seq Age Sex Outcome Treatment
    1