BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3000590 · Received March 12, 2013

    Report

    Report Number
    0009617544-2013-00070
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 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. 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 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 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 IS BEING CONDUCTED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT DURING SURGERY THE TIP OF THE REPORTED DEVICE HAS BEEN BROKEN OFF. NO ADVERSE CONSEQUENCES REPORTED TO SALES REP.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT DURING SURGERY THE TIP OF THE REPORTED DEVICE HAS BEEN BROKEN OFF. NO ADVERSE CONSEQUENCES REPORTED TO SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104042 XIA 3 TITANIUM TORQUE WRENCH TORQUE WRENCH LXH STRYKER SPINE-FRANCE 114663

    Patients

    Seq Age Sex Outcome Treatment
    1