BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 2232601 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01129
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBE WAS RETURNED FOR EVALUATION. PROBE TIP BENT IN MULTIPLE LOCATIONS AND BROKEN, WITH A ~22MM PORTION OF THE PROBE MISSING AND NOT RETURNED FOR ANALYSIS. THE SUBMITTED PICTURES APPEAR TO DISPLAY A QUASI-BRITTLE FRACTURE SURFACE WITH NO VISIBLE INDICATIONS OF FATIGUE. THE BENT TIP, ALONG WITH THE NATURE AND LOCATION OF THE FRACTURE 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 TIP OF THE PEDICLE PROBE BROKE OFF. NO 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 INSTRUMENT MANUFACTURING NA ID06E013A

    Patients

    Seq Age Sex Outcome Treatment
    1