BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II TORQUE WRENCH

    MDR report key: 3908790 · Received July 2, 2014

    Report

    Report Number
    0009617544-2014-00285
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; VISUAL INSPECTION; COMPLAINT HISTORY; RESULTS: THE MAIN CAUSE OF THE BREAKAGE WAS DETERMINED TO BE THE INCORRECT HEAT TREATMENT OF THE TORSION SHAFT MATERIAL WHICH RESULTED IN EMBRITTLEMENT. CONCLUSION: THE HEX-TIP ON THE RETURNED INSTRUMENT WAS CONFIRMED TO BE BROKEN. THIS IS THE 1ST COMPLAINT TO HAVE BEEN RECEIVED ON LOT 111071 RELATING TO THE BREAKAGE OF THE HEX-TIP. A CAPPA WAS ENACTED TO CORRECT THE PROBLEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN TIP OF XIA TORQUE WRENCH WAS FOUND AT STRYKER SPINE WHEN INSTRUMENTS RETURNED FROM (B)(4) DEALER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROKEN TIP OF XIA TORQUE WRENCH WAS FOUND AT STRYKER SPINE WHEN INSTRUMENTS RETURNED FROM (B)(6) DEALER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388468 XIA II TORQUE WRENCH IMPLANT-TORQUE WRENCH LXH STRYKER SPINE-FRANCE 117071

    Patients

    Seq Age Sex Outcome Treatment
    1