BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE T HANDLE

    MDR report key: 3143017 · Received June 3, 2013

    Report

    Report Number
    0009617544-2013-00206
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, FUNCTIONAL INSPECTION, DEVICE HISTORY REVIEW, AND COMPLAINT HISTORY REVIEW. RESULTS: VISUAL INSPECTION: RETURNED T-HANDLE PRESENTS BROKEN WING AT THE TIP OF THE INSTRUMENT. EVENT OCCURRED WHILE MALLETING OFF A TRIAL THAT WAS PERCEIVED AS STUCK IN THE HANDLE. HENCE SUCH EVENT WOULD BE THE RESULT OF EXCESSIVE LOADS. FUNCTIONAL INSPECTION: INSTRUMENT IS BROKEN AND THEREFORE THIS SECTION IS NOT APPLICABLE. INSTRUMENT WOULD NEVERTHELESS STILL ACCEPT A SHAFT IN ITS GROOVE ATTESTING THAT THE GROOVE WAS CORRECTLY MANUFACTURED. DEVICE HISTORY REVIEW: NO RELEVANT DEVIATION IN REGARDS TO THE FAILURE MODE REPORTED WAS NOTED. CONCLUSION: THE INSTRUMENT WAS RETURNED, CONFIRMED BROKEN AND INSPECTED. NO ANOMALY THAT COULD BE ASSOCIATED WITH THE EVENT WAS REPORTED DURING THE MANUFACTURING OF THIS BATCH. SUCH BREAKAGE IS LIKELY THE RESULT OF EXCESSIVE TORQUE LOADS. INSTRUMENT DAMAGE MAY ALSO BE THE RESULT OF PREVIOUS CONDITION OF USE THAT MAY HAVE WEAKENED THE DEVICE WINGS (THIS HANDLE BEING POSSIBLY USED WITH REAMERS, SHAVERS, TO SCRAP THE DISC FROM THE ENDPLATES OF TWO VERTEBRAE DURING PREVIOUS SURGERY STEP). THE DAMAGED WAS OBSERVED TRYING TO REMOVE A TRIAL AND MALLETING THE DEVICE IN THE COURSE OF SURGERY, IT DID NOT COMPROMISE THE SUCCESS OF THIS ONE BUT INVOLVED VERY MINOR DELAY OF 5 MINUTES, THERE HAS BEEN NO MEDICAL CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "QUICK CONNECT HANDLE WAS STUCK ON THE TRIAL, HAD TO MALLET IT OFF, PIECE OF QUICK CONNECT HANDLE FRACTURED. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "QUICK CONNECT HANDLE WAS STUCK ON THE TRIAL, HAD TO MALLET IT OFF, PIECE OF QUICK CONNECT HANDLE FRACTURED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244963 RELIANCE T HANDLE INSTRUMENT LXH STRYKER SPINE-FRANCE 114235

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR