BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREWDRIVER

    MDR report key: 3171384 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02314
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. VISUALLY CONFIRMED APPROXIMATELY ~3MM OF THE INSTRUMENT TIP HAS BEEN BROKEN OFF, CONSISTENT WITH INTERFACE DURING USAGE. DIMENSIONAL INSPECTION OF THE INNER SHAFT DIAMETER CONFIRMED CONFORMANCE TO PRINT SPECIFICATION. FRACTURE SURFACE ANALYSIS REVEALS A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL MOVEMENT, CONSISTENT WITH TORSIONAL OVERLOAD, CONSISTENT WITH TORSIONAL OVERLOAD CONDITION. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S INITIAL DIAGNOSIS WAS A TRAUMATIC INJURY WITH FIXATION LEVEL 2-ABOVE AND 2-BELOW ON L3. IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE DURING FINAL TIGHTENING. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271973 SCREWDRIVER SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC NA GB12L003

    Patients

    Seq Age Sex Outcome Treatment
    1