BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 2992538 · Received March 7, 2013

    Report

    Report Number
    0009617544-2013-00063
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    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 RECEIVED DEVICE IS BROKEN AT THE HEXAGONAL TIP. SPECIFICALLY, THE BREAKAGE OCCURRED ON THE JUNCTION BETWEEN THE HEXAGONAL AND CYLINDRICAL PARTS OF THE INNER SHAFT. MACHINING LINES ARE VISIBLE ON THE 8.5MM PART OF INNER SHAFT; HOWEVER, THEY ARE NOT VERY DEEP. 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. 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 21 COMPLAINTS INVOLVING 21 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 WRENCH WHICH WERE MANUFACTURED AFTER THE INITIAL CAPA WAS IMPLEMENTED. THE TORQUE WRENCH INVOLVED IN THE PRESENT COMPLAINT WAS MANUFACTURED AFTER THIS CAPA AND THE OBSERVATIONS MADE DURING INSPECTION OF THE RETURNED DEVICE LET 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 PROCESS IS BEING CONDUCTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT DURING SURGERY UPON FINAL TIGHTENING OF THE XIA BLOCKER THE TIP ON THE INSTRUMENT BROKE OFF."

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT DURING SURGERY UPON FINAL TIGHTENING OF THE XIA BLOCKER THE TIP ON THE INSTRUMENT BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97420 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E047

    Patients

    Seq Age Sex Outcome Treatment
    1