BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET SCREW RETAINING DRIVER

    MDR report key: 3884471 · Received June 19, 2014

    Report

    Report Number
    1030489-2014-02811
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE FIRST COMPONENT HAS BROKEN OFF. THE FRACTURE IS CONSISTENT WITH OVERLOAD. IT HAS BEEN IDENTIFIED THAT THE SLOTS HAVE BEEN ORIENTATED INCORRECTLY FROM THE SUPPLIER. THE INCORRECT ORIENTATION HAS SHOWN TO CAUSE THE SHAFT TO FAIL AT A LOWER TORQUE SPEC. THE SLOTS IN THE OUTER SHAFT HAVE BEEN INCORRECTLY PLACED BY THE MANUFACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON FINAL TIGHTENING AND BREAKING OFF OF SET SCREWS, THE INSTRUMENT SNAPPED IN HALF DURING A MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AT L4-L5. THE INSTRUMENT SPLIT AND BROKE 2/3 OF THE WAY DOWN THE SHAFT. LEVELS IMPLANTED WERE L4-L5. THERE WERE NO PATIENT COMPLICATIONS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360592 SET SCREW RETAINING DRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA TI13J0181

    Patients

    Seq Age Sex Outcome Treatment
    1 SET SCREW HOLDER