BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3183106 · Received June 21, 2013

    Report

    Report Number
    0009617544-2013-00234
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW VISUAL INSPECTION: THE RETURNED TORQUE WRENCH WAS EXAMINED AND THE HEX TIP WAS CONFIRMED TO BE SEPARATED FROM THE TORQUE WRENCH. THE BREAKAGE OCCURRED WITHIN THE INNER CYLINDER, EXPOSING THE INNER PIN OF THE TORQUE WRENCH. FUNCTIONAL INSPECTION: NOT APPLICABLE DUE TO THE HEX TIP BEING BROKEN. DEVICE HISTORY REVIEW: ONE UNIT WAS SCRAPPED AS A RESULT OF THE ISSUE. A FUNCTIONAL TEST AND A CHECK OF APPEARANCE AND SHAPE WERE DONE ON ALL REMAINING UNITS FROM THE BATCH AND MET SPECIFICATIONS. THE RETURNED SAMPLE WAS VISUALLY EXAMINED AND BREAKAGE OF THE HEX TIP WAS CONFIRMED. A PREVIOUS INVESTIGATION WAS PERFORMED FOR A SIMILAR COMPLAINT IN WHICH THE SAMPLE WAS SENT FOR EXTERNAL TESTING. THE CAUSE OF THE BREAKAGE AT THIS LOCATION IS WITHIN THE SCOPE OF A CORRECTIVE ACTION INITIATED EARLIER THIS YEAR FOR THE SAME ISSUE WITH THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "THE TORQUE WRENCH WAS BROKEN DURING THE 3.SCREW FINAL TIGHTENING. THE REST OF THE 3 SCREW WERE TIGHTENED BY UNIVERSAL TIGHTENER."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TORQUE WRENCH WAS BROKEN DURING THE 3 SCREW FINAL TIGHTENING. THE REST OF THE 3 SCREWS WERE TIGHTENED BY UNIVERSAL TIGHTENER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283782 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E048

    Patients

    Seq Age Sex Outcome Treatment
    1