BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3013390 · Received March 20, 2013

    Report

    Report Number
    0009617544-2013-00086
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 20, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY ANALYSIS, LABELING REVIEW: THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE TIP OF THE RETURNED DEVICE IS BROKEN. THE BREAKAGE IS LOCATED ON THE JUNCTION BETWEEN HEXAGONAL AND CYLINDRICAL PARTS OF THE INNER SHAFT. MACHINING LINES ARE VISIBLE ON THE 8.5MM CYLINDRICAL PART OF THE SHAFT. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE FUNCTIONAL TEST AND VERIFICATION OF APPEARANCE AND SHAPE IS DONE ON THE ENTIRE BATCH. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. NO INDICATION OF MATERIAL OR MANUFACTURING DEFECT COULD BE FOUND. THE RESULTS OF THE COMPLAINT HISTORY ANALYSIS FOR THIS SAME ISSUE REVEALED A TOTAL 28 COMPLAINTS INVOLVING 28 INSTRUMENTS RECEIVED FOR TORQUE WRENCH TIP BREAKAGE ON DEVICES WHICH WERE MANUFACTURED AFTER AN INTERNAL CORRECTIVE ACTION WAS INITIATED AND IMPLEMENTED. THIS FIRST CAPA WAS INITIATED IN ORDER TO FIND THE FAILURE CAUSE AND PROPOSE CORRECTIVE AND PREVENTIVE ACTIONS, INCLUDING A DESIGN CHANGE OF THE TORQUE WRENCH TO PREVENT TIP BREAKAGE. AN ALTERNATIVE LINK BETWEEN THE TUBE (OUTER SHAFT) AND INNER SHAFT WITHOUT PRESS FIT PIN AND WELDING WAS IMPLEMENTED. A NON-CONFORMANCE WAS INITIATED FOLLOWING THE RECURRENT ISSUE OF BREAKAGE OF THE HEX TIP OF THE XIA 3 TORQUE WRENCHES WHICH WERE MANUFACTURED AFTER THE INITIAL CAPA WAS IMPLEMENTED. THE TORQUE WRENCH INVOLVED IN THE PRESENT COMPLAINT WAS MANUFACTURED AFTER THE IMPLEMENTATION OF THIS CAPA AND THE OBSERVATIONS MADE DURING INSPECTION OF THE RETURNED DEVICE LED US TO CONCLUDE THAT THE PRESENT COMPLAINT ENTERS INTO THE SCOPE OF THE NON-CONFORMANCE. CONCLUSION: THE DEVICE FAILURE DIRECTLY CAUSED THE EVENT AND THE INSTRUMENT DESIGN CONTRIBUTED TO THIS EVENT. AS THIS ISSUE HAS BEEN NOTED ON PREVIOUS COMPLAINTS FOR THIS PRODUCT SINCE THE DESIGN CHANGE, AN INTERNAL NON-CONFORMANCE HAS BEEN OPENED AND AN EXTENDED INVESTIGATION VIA THE NON-CONFORMANCE SYSTEM IS BEING CONDUCTED TO ADDRESS THIS ISSUE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A NURSE IN POLAND THAT A TORQUE WRENCH BROKE DURING SURGERY. THE SCREW WAS FULLY INSERTED AND THE WRENCH BROKE DURING THE LAST TURN. THE BROKEN PARTS WERE SUCCESSFULLY REMOVED WITH PLIERS WITH NO INJURIES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A NURSE IN (B)(6) THAT A TORQUE WRENCH BROKE DURING SURGERY. THE SCREW WAS FULLY INSERTED AND THE WRENCH BROKE DURING THE LAST TURN. THE BROKEN PARTS WERE SUCCESSFULLY REMOVED WITH PLIERS WITH NO INJURIES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115826 XIA 3 TITANIUM TORQUE WRENCH TORQUE WRENCH LXH STRYKER SPINE-FRANCE 10E046

    Patients

    Seq Age Sex Outcome Treatment
    1