BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 2945651 · Received February 6, 2013

    Report

    Report Number
    0009617544-2013-00012
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY AND RISK ASSESSMENT ANALYSIS. RESULTS: VISUAL INSPECTION: THE HEX TIP IS BROKEN. BREAKAGE IS LOCATED AT THE BORDER BETWEEN HEXAGONAL PART AND CYLINDRICAL PART OF THE TIP. NUMEROUS MACHINING LINES ARE VISIBLE ON THE 8.5MM DIAMETER ZONE. DEVICE HISTORY REVIEW: DHR REVIEW IS DONE FOR BATCH #11E046. CONFORMITY OF HEXA 5 SHAPE, FUNCTIONAL TESTING, APPEARANCE AND SHAPE WERE CHECKED ON ENTIRE BATCH. NO NON CONFORMITIES OR DEVIATIONS LINKED WITH REPORTED EVENT WERE NOTED DURING MANUFACTURING PROCESS. COMPLAINT HISTORY: A TOTAL OF 16 COMPLAINTS INVOLVING 16 UNITS HAVE BEEN RECEIVED RELATING TO TIP FRACTURE DURING FINAL TIGHTENING AFTER DESIGN CHANGE IN 2010. RISK ANALYSIS: THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SIGNIFICANT DELAYS IN SURGERY AS A RESULT OF THE REPORTED EVENT. THE SEVERITY THRESHOLDS HAVE NOT BEEN BREACHED. CONCLUSION: IT WAS REPORTED ABOUT BREAKAGE OF HEX TIP OF XIA 3 TORQUE WRENCH OCCURRED DURING THE SURGERY. AT RECEPTION OF THE DEVICE AT INVESTIGATION SITE, THE REPORTED BREAKAGE WAS CONFIRMED. THE INVOLVED INSTRUMENT HAS SERIAL #11E046 AND WAS MANUFACTURED AFTER APPLICATION OF CORRECTIVE ACTIONS WITHIN CAPA 2010-064. DUE TO THE RECURRENT BREAKAGE OF HEX TIP OF XIA 3 TORQUE WRENCH MANUFACTURED AFTER CAPA 2010-064, NC 2012-043 WAS INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 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. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN TORQUE WRENCH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING XIA3 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. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN TORQUE WRENCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51049 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E046

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR