BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE T HANDLE

    MDR report key: 3902654 · Received June 30, 2014

    Report

    Report Number
    0009617544-2014-00280
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; FUNCTIONAL INSPECTION; RESULTS: ACCORDING TO A SIMILAR INVESTIGATION, THE ESTABLISHED 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-OPERATIVLEY. 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. NO HARM OR 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 THE SURGEON WAS USING THE MALLET AND POUNDING ON THE RELIANCE LITE T HANDLE AND THE INNER SHAFT BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING THE MALLET AND POUNDING ON THE RELIANCE LITE T HANDLE AND THE INNER SHAFT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381032 RELIANCE T HANDLE INSTRUMENT-HANDLE LXH STRYKER SPINE-FRANCE 422841

    Patients

    Seq Age Sex Outcome Treatment
    1