BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II TORQUE WRENCH

    MDR report key: 3202799 · Received July 2, 2013

    Report

    Report Number
    0009617544-2013-00255
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 23, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE CUSTOMER REPORTED EVENT OF THE HEX TIP BREAKAGE OF THE XIA 3 TITANIUM TORQUE WRENCH WAS CONFIRMED VIA A VISUAL EVALUATION. THIS TYPE OF BREAKAGE HAS BEEN INVESTIGATED AND ADDRESSED UNDER CAPA (B)(4); THE ROOT CAUSE WAS AN INADEQUATE HEAT TREATMENT PROCESS IN 2007, RESULTING IN EMBRITTLED PARTS. THE MATERIAL WAS NOT HEAT TREATED CORRECTLY RESULTING IN HIGH HARDNESS (WHICH MAKES THE METAL BRITTLE). THE CAUSES IDENTIFIED IN THIS CAPA ARE ALL CONSISTENT WITH THE FINDINGS PRESENTED IN THE THIRD PARTY PERFORMED ANALYSIS. ADDITIONALLY, THE MANUFACTURING RECORDS OF THIS SAMPLE WERE ALSO REVIEWED AND ALL UNITS WITHIN THE LOT WERE INSPECTED AND ACCEPTED PER STRYKER SPECIFICATIONS. CONCLUSION: 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.

    Description of Event or Problem · 1

    AT THE END OF THE SCOLIOSIS SURGERY DURING FINAL TIGHTENING, THE TORQUE WRENCH BROKE.

    Description of Event or Problem · 1

    AT THE END OF THE SCOLIOSIS SURGERY DURING FINAL TIGHTENING, THE TORQUE WRENCH BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301985 XIA II TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE 125710

    Patients

    Seq Age Sex Outcome Treatment
    1