BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3200963 · Received July 2, 2013

    Report

    Report Number
    0009617544-2013-00250
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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; RESULTS: AS OF 31-OCT-2013 NO DEVICE HAS BEEN RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO BE A XIA 3 TITANIUM TORQUE WRENCH, LOT # R127647, CAT # 48237028. MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT # R127647 AND NONCONFORMITIES WERE IDENTIFIED. ALL UNITS PASSED FUNCTIONAL, DIMENSIONAL, AND VISUAL INSPECTION. THE CUSTOMER REPORTED EVENT OF A XIA 3 TITANIUM TORQUE WRENCH TIP BREAKAGE WAS CONFIRMED VIA A REVIEW OF THE ATTACHED IMAGE, WHICH CLEARLY SHOWS A BROKEN TORQUE WRENCH TIP. FURTHER CONFIRMATION CAN BE OBTAINED IN THE CORRESPONDENCE WITH THE INTERNATIONAL CONTACT. THERE IS A CURRENT CAPA OPEN, WHICH ADDRESSES TORQUE WRENCH BREAKAGES. HOWEVER, BECAUSE THE SAMPLE WAS NOT RETURNED, THE LOT # CANNOT BE CONFIRMED AND IT IS UNKNOWN IF THIS CAPA APPLIES. ACCORDING TO THIS CAPA THE ROOT CAUSE OF THE TIP BREAKAGES IS IMPROPER HEAT TREATMENT DURING MANUFACTURING. CONCLUSION: NO SAMPLE HAS BEEN RECEIVED SO A DEVICE INSPECTION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE TORQUE WRENCH BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE TORQUE WRENCH BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303107 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE R127647

    Patients

    Seq Age Sex Outcome Treatment
    1