BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH SHORT

    MDR report key: 3183047 · Received June 21, 2013

    Report

    Report Number
    0009617544-2013-00236
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 RETURNED SAMPLE WAS VISUALLY EXAMINED AND BREAKAGE OF THE HEX TIP WAS CONFIRMED. THE LOCATION OF THE BREAK IS CENTRALIZED NEAR THE JUNCTION OF THE HEX TIP BASE AND THE INNER CYLINDER. 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 THIS TYPE OF BREAKAGE IS CURRENTLY BEING INVESTIGATED IN A CAPA PROJECT.

    Additional Manufacturer Narrative · 1

    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 AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SURGEON WAS TIGHTENING THE BLOCKER AND THE TIP OF THE TORQUE WRENCH BROKE OFF. THE SALES REP HAD ANOTHER ONE IN THE SET."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "SURGEON WAS TIGHTENING THE BLOCKER AND THE TIP OF THE TORQUE WRENCH BROKE OFF. THE SALES REP HAD ANOTHER ONE IN THE SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282477 XIA 3 TITANIUM TORQUE WRENCH SHORT INSTRUMENT LXH STRYKER SPINE-FRANCE 11A957

    Patients

    Seq Age Sex Outcome Treatment
    1