BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3202790 · Received July 2, 2013

    Report

    Report Number
    0009617544-2013-00254
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULTS: VISUAL INSPECTION: THE RETURNED TORQUE WRENCH WAS EXAMINED UPON RECEIPT AND THE HEX TIP WAS CONFIRMED TO BE BROKEN. UNDER MAGNIFICATION IT COULD BE SEEN THAT THE BREAK OCCURRED AT THE INTERFACE BETWEEN THE HEX TIP AND THE INNER SHAFT OF THE WRENCH. FUNCTIONAL INSPECTION: COULD NOT BE PERFORMED DUE TO BREAKAGE OF HEX TIP. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATIONS IN REGARDS TO THE FAILURE MODE WERE REPORTED UPON REVIEW OF THE MANUFACTURING RECORDS. CONCLUSION: THE REPORTED EVENT OF THE HEX TIP BREAKAGE OF THE XIA 3 TITANIUM TORQUE WRENCH WAS CONFIRMED VIA A VISUAL INSPECTION. A PREVIOUS INVESTIGATION WAS PERFORMED FOR A SIMILAR COMPLAINT IN WHICH THE SAMPLE WAS SENT FOR EXTERNAL TESTING. THIS TESTING CONCLUDED THAT THE BREAKAGE WAS DUE TO SEMI-FRAGILE SUDDEN RUPTURE PROCESS INITIATED BY AN IMPORTANT NOTCH EFFECT. THE BREAKAGE WAS INITIATED PRECISELY AT THE FILET ZONE OF THE SHOULDER BETWEEN THE HEXAGONAL EXTREMITY AND THE 8.5MM DIAMETER ZONE. ALSO, THE RADIUS OF THE FILET WAS VERY LOW, BUT STILL WITHIN THE SPECIFICATION OF THE DRAWING. THE CAUSE OF THE BREAKAGE AT THIS LOCATION IS CURRENTLY BEING INVESTIGATED IN A CAPA.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF XIA3 TORQUE WRENCH BROKE. THERE IS NO REPORT FROM THE HOSPITAL.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF XIA3 TORQUE WRENCH BROKE. THERE IS NO REPORT FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301951 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 114664

    Patients

    Seq Age Sex Outcome Treatment
    1