BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3142862 · Received June 3, 2013

    Report

    Report Number
    0009617544-2013-00203
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULT: THE REPORTED LOT # 11E044 FALLS INTO THE SCOPE OF CAPA (B)(4). POTENTIAL ROOT CAUSES FROM THIS CAPA INCLUDE GRAIN BOUNDARY ATTACK, WHICH MAGNIFY STRESS CONCENTRATIONS, AN INSUFFICIENT FILLET AT THE RADIUS BETWEEN THE HEX AND THE MAIN CYLINDER, AN INADEQUATE HEAT TREAT PROCESS, AND INADEQUATE MANUFACTURING TRANSFER TO LAB MEDICAL IN 2007. HOWEVER, BECAUSE THE PRODUCT WAS NOT RETURNED AND THE REPORTED EVENT NOT CONFIRMED, IT CANNOT BE DETERMINED WHETHER THIS CAPA AND ITS FINDINGS APPLY TO THIS COMPLAINT. CONCLUSION: NO SAMPLE WAS RECEIVED FOR INVESTIGATION, SO THE CUSTOMER REPORTED EVENT OF A TIP BREAKAGE COULD NOT BE CONFIRMED. FURTHERMORE, ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AND THE INVESTIGATION IS INCONCLUSIVE. ADDITIONALLY, THE MANUFACTURING RECORDS OF THIS SAMPLE'S REPORTED LOT WERE ALSO REVIEWED AND WERE INSPECTED AND ACCEPTED PER STRYKER SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MENTIONED DEVICE BROKE DURING SURGERY. THERE WAS A DELAY OF 10 MIN. A REPLACEMENT WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MENTIONED DEVICE BROKE DURING SURGERY. THERE WAS A DELAY OF 10 MIN. A REPLACEMENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245349 XIA 3 TITANIUM TORQUE WRENCH SURGICAL TORQUE WRENCH LXH STRYKER SPINE-FRANCE 11E044

    Patients

    Seq Age Sex Outcome Treatment
    1