BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    MDR report key: 3202446 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02889
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW CONFIRMS DISTAL TAB BROKEN OFF ON THE SHAFT. OPTICAL EXAMINATION OF THE FRACTURE REVEALS A FAIRLY BRITTLE FRACTURE SURFACE WITH NO INDICATION OF FATIGUE. WITNESS MARK NOTED AT THE BASE OF THE FRACTURE. THE MORPHOLOGY OF THE FRACTURE SUGGESTS THE POSSIBLE DIRECTION OF PROPAGATION, WITH EVIDENCE OF SHEAR LIPS ON THE INTERIOR SIDE OF THE TAB. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BEND STRESS OVERLOAD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL PIECE OF THE TIP OF THE DRIVER BROKE OFF. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301192 MANUAL ORTHOPEDIC SURGICAL INSTRUMENT SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA GB11K011

    Patients

    Seq Age Sex Outcome Treatment
    1