BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3260194 · Received August 1, 2013

    Report

    Report Number
    0009617544-2013-00290
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 8, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    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 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 (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

    IT WAS REPORTED THAT THE TIP OF THE TORQUE WRENCH BROKE DURING FINAL TIGHTENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE TORQUE WRENCH BROKE DURING FINAL TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359871 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1