BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 3142797 · Received June 3, 2013

    Report

    Report Number
    0009617544-2013-00204
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, AND DEVICE HISTORY REVIEW. RESULT: MANUFACTURING FILES WERE REVIEWED FOR BATCH #11E044. A FAC WAS IDENTIFIED WITH THE HEX PER FORM QC 11447. HOWEVER, THE ITEMS WERE RECHECKED AND WERE ACCEPTED. A FUNCTIONAL TEST AND A CHECK OF APPEARANCE AND SHAPE WERE DONE ON A SAMPLE OF 5 UNITS FROM THE LOT PER FORM QC 041 AND FOUND TO MEET SPECIFICATIONS. NO SAMPLE WAS RETURNED FOR EVALUATION, SO AN INSPECTION COULD NOT BE PERFORMED. CONCLUSION: NO SAMPLE WAS RECEIVED FOR INVESTIGATION, SO THE CUSTOMER REPORTED EVENT OF A 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 A TORQUE WRENCH BROKE DURING STERILIZATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TORQUE WRENCH BROKE DURING STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245194 XIA 3 TITANIUM TORQUE WRENCH SURGICAL TORQUE WRENCH LXH STRYKER SPINE-FRANCE 11E044

    Patients

    Seq Age Sex Outcome Treatment
    1