BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE T HANDLE

    MDR report key: 3823480 · Received May 21, 2014

    Report

    Report Number
    0009617544-2014-00228
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RESULTS: THE POSSIBLE CAUSE OF THE EVENT IS EXCESSIVE TORQUE LOAD APPLIED BY THE USER. THIS WAS DETERMINED BY A MATERIALS ANALYSIS PERFORMED FOR A SIMILAR COMPLAINT ON A T-HANDLE DEVICE THAT FRACTURED INTRA-OPERATIVELY. CONCLUSION: THE CUSTOMER REPORTED EVENT OF RELIANCE T HANDLE FRACTURE WAS CONFIRMED VIA A VISUAL INSPECTION. NO NEW HARM OR HAZARD HAS BEEN IDENTIFIED AS A RESULT OF THIS EVENT. A 2 MINUTE DELAY WAS REPORTED. NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING A SHAVER AND A T HANDLE FROM THE ARIA SET, THE SURGEON WAS TWISTING THE SHAVER TO SCRAPE THE END PLATES AND THE T HANDLE BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WAS USING A SHAVER AND A T HANDLE FROM THE ARIA SET, THE SURGEON WAS TWISTING THE SHAVER TO SCRAPE THE END PLATES AND THE T HANDLE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303659 RELIANCE T HANDLE INSTRUMENT-T HANDLE LXH STRYKER SPINE-FRANCE 115979

    Patients

    Seq Age Sex Outcome Treatment
    1