BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH SHORT

    MDR report key: 2822993 · Received October 24, 2012

    Report

    Report Number
    9617544-2012-00458
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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

    DR. (B)(6) WAS DOING A T3 TO L3 SCOLIOSIS CASE. HE FINAL TIGHTENED ABOUT 8 BLOCKERS AND ON THE PATIENTS LEFT SIDE AND AROUND THE T8 LEVEL AND WE HEARD A SNAP. THE HEX TIP BROKE AND IS NOW STUCK ON THE BLOCKER. HE USED A DRILL AND MADE A SMALL HOLE IN THE BROKEN TIP AND WAS ABLE TO EXTRACT IT THEN WITH A SNAP. HE DID ONE MORE WASH AND CONTINUED TO FINAL TIGHTEN WITH THE OTHER TORQUE WRENCH THAT WE HAD. THIS ENTIRE PROCESS ADDED ABOUT 3 TO 5 MINUTES TO THE CASE. THE FINAL X-RAY WAS DETERMINED BY THE RADIOLOGIST THAT NO PIECES OR DEBRIS BESIDES THE IMPLANTS WERE INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM TORQUE WRENCH SHORT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 11A957

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK