BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 4120997 · Received September 26, 2014

    Report

    Report Number
    0009617544-2014-00411
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE HEX-TIP ON THE RETURNED INSTRUMENT WAS CONFIRMED TO BE BROKEN. 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

    IT WAS REPORTED THAT DURING FINAL CLOSING OF THE BLOCKER IN A XIA3 IMPLANT THE TIP OF THE TORQUE WRENCH BROKE OFF. THE TEAM USED ANOTHER TORQUE WRENCH FOR THE REMAINDER OF THE SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FINAL CLOSING OF THE BLOCKER IN A XIA3 IMPLANT THE TIP OF THE TORQUE WRENCH BROKE OFF. THE TEAM USED ANOTHER TORQUE WRENCH FOR THE REMAINDER OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601446 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT-TORQUE WRENCH LXH STRYKER SPINE-FRANCE 08D292

    Patients

    Seq Age Sex Outcome Treatment
    1