BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 1993622 · Received January 6, 2011

    Report

    Report Number
    9617544-2010-00514
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HXC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "AFTER DR (B)(6) PUT IN APPROXIMATELY 20 REDUCTION SCREWS AND WAS HAPPY WITH THE CORRECTION OF THE SCOLIOSIS DEFORMITY, HE BEGAN TO FINAL TIGHTEN THE XIA3 BLOCKERS. HE HAD ALREADY TIGHTENED 5 BLOCKERS AND WAS IN THE PROCESS OF THE 6TH WHEN THE TIP OF THE TORQUE WRENCH SNAPPED OFF, DR (B)(6) WAS ABLE TO REMOVE THE BROKEN TIP FROM THE PATIENT. WE HAD A BACK UP COMPLEX SPINE SET FOR THE CASE AND WERE ABLE TO PROCEED WITH FINAL TIGHTENING. DR (B)(6) USED THE TORQUE WRENCH PROPERLY FOR ITS DESIGNED USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT HXC STRYKER SPINE BORDEAUX NA 093653

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK