BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II TORQUE WRENCH

    MDR report key: 2844323 · Received November 8, 2012

    Report

    Report Number
    9617544-2012-00490
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING XIA SURGERY, WHEN THE SURGEON USED THE TORQUE WRENCH AND DID THE FINAL TIGHTENING OF THE BLOCKER, THE TIP OF THE TORQUE WRENCH BROKE. THEREFORE THE SURGEON TIGHTENED THE BLOCKER USING THE UNIVERSAL TIGHTENER. DURING THE OPERATION, IN ORDER TO REMOVE THE BROKEN PIECE OF THE TIP OF TO TORQUE WRENCH, 20 MINUTES WERE REQUIRED. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN TORQUE WRENCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 11E038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK