BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1971022 · Received January 26, 2011

    Report

    Report Number
    1030489-2011-00073
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING
    Product Code
    HXW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMS TIP BREAKAGE. MICROSCOPIC EXAMINATION REVEALS A QUASI-BRITTLE FRACTURE SURFACE WITH NO INDICATION OF FATIGUE, AND RIVERLINES CONSISTENT WITH OVERLOAD. THE LOCATION OF TIP PLASTIC DEFORMATION AND WITNESS MARKS ON THE BROKEN OFF PORTION OF THE TIP SUGGESTS IMPROPER TECHNIQUE MAY HAVE BEEN UTILIZED, WITH THE ROD NOT FULLY ENGAGED INTO THE MOUTH OF THE INSTRUMENT, RESULTING IN AN OVERLOAD CONDITION, AND RESULTING IN THE FOREGOING BREAKAGE. 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 PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE ROD BENDER BROKE WHILE BENDING THE ROD INSIDE THE PATIENT. THE BROKEN TIP WAS RETRIEVED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT BENDER HXW MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING NA FA10E001

    Patients

    Seq Age Sex Outcome Treatment
    1 ROD