BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3242374 · Received July 23, 2013

    Report

    Report Number
    0009617544-2013-00277
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 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

    THIS DEVICE WAS IDENTIFIED INCORRECTLY DURING INITIAL INTAKE TO BE A SHORT TORQUE WRENCH; THEREFORE, THE COMPLAINT WAS RE-OPENED TO MAKE THE NECESSARY CORRECTIONS AND SUBMIT THE INITIAL EMDR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING THE CLOSURE OF THE ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. 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. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: MANUFACTURING FILES ARE REVIEWED. NO NON CONFORMITIES OR DEVIATIONS LINKED WITH REPORTED ISSUE ARE FOUND. FUNCTIONAL TESTING WAS DONE FOR ENTIRE BATCH DURING QUALITY CONTROL. COMPLAINT HISTORY: SUPER DATABASE: (B)(4) COMPLAINTS INVOLVING (B)(4) DEVICES ARE RECEIVED FOR HEX BREAKAGE OF TORQUE WRENCH MANUFACTURED AFTER CAPA (B)(4). DURING VISUAL INSPECTION OF (B)(4) DEVICES THE MACHINING LINES ON THE 8.5MM DIAMETER ZONE WERE OBSERVED. (B)(4) DEVICES FROM BATCH #(B)(4) INVOLVED IN COMPLAINTS (B)(4) AND (B)(4) HAVE LESS REMARKABLE MACHINING LINES THAN ON OTHER (B)(4) DEVICES. 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 #(B)(4) AND WAS MANUFACTURED AFTER APPLICATION OF CORRECTIVE ACTIONS WITHIN CAPA (B)(4). DUE TO THE RECURRENT BREAKAGE OF HEX TIP OF XIA 3 TORQUE WRENCH AND TORQUE WRENCH SHORT MANUFACTURED AFTER CAPA (B)(4), NC (B)(4) 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 TORQUE WRENCH OF XIA3 ELEGANCE. THE SURGEON WAS NOT ABLE TO REMOVE THE TIP OF BROKEN TORQUE WRENCH FROM THE PATIENT INSIDE OF THE BODY. 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 TORQUE WRENCH OF XIA3 ELEGANCE. THE SURGEON WAS NOT ABLE TO REMOVE THE TIP OF BROKEN TORQUE WRENCH FROM THE PATIENT INSIDE OF THE BODY. THE SURGEON REQUESTED THE INVESTIGATION OF THE BROKEN TORQUE WRENCH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344147 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E045

    Patients

    Seq Age Sex Outcome Treatment
    1