BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 1790335 · Received August 5, 2010

    Report

    Report Number
    1030489-2010-01021
    Event Type
    Malfunction
    Date Received
    August 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DRIVER WAS RETURNED FOR EVALUATION. MACROSCOPIC EXAMINATION CONFIRMS TIP BREAKAGE OF ONE SIDE OF SCREWDRIVER SHAFT. MICROSCOPIC EXAMINATION OF FRACTURE REVEALS A QUASI-BRITTLE FRACTURE WITH NO INDICATION OF TORSION OR FATIGUE. ADDITIONALLY, RIVER LINES SUGGEST THE DIRECTION OF FRACTURE AND PROVIDE EVIDENCE OF OVERLOAD. THE FRACTURE ON ONE SIDE OF THE INSTRUMENT, IN ADDITION TO THE NATURE OF THE FRACTURE SUGGEST BEND STRESS OVERLOAD. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY AND APPLICABLE NONCONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE SCREWDRIVER BROKE WHILE REMOVING A SCREW. THE TIP OF THE DRIVER WAS REMOVED FROM THE PT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK NA PT10919

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT:| EXPLANT:| BONE SCREW: