BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3233673 · Received July 18, 2013

    Report

    Report Number
    0009617544-2013-00271
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 8.5 MM DIAMETER ZONE OF THE WRENCH. FUNCTIONAL INSPECTION: NOT APPLICABLE BECAUSE THERE WAS VISUAL CONFIRMATION OF FAILURE. 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, 8.5 MM DIAMETER ZONE. 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 A SIGNIFICANT 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING TIGHTENING OF THE SCREW THE MENTIONED DEVICE HAS BEEN BROKEN AT THE TIP. THERE WAS A DELAY OF 15 MIN."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING TIGHTENING OF THE SCREW THE MENTIONED DEVICE HAS BEEN BROKEN AT THE TIP. THERE WAS A DELAY OF 15 MIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334865 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 11E048

    Patients

    Seq Age Sex Outcome Treatment
    1