BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 2990622 · Received March 5, 2013

    Report

    Report Number
    0009617544-2013-00056
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, RISK ASSESSMENT. RESULTS: THERE HAVE BEEN 117 PREVIOUS COMPLAINTS FOR THIS DEVICE. PREVIOUS INVESTIGATIONS CONCLUDED THE FAILURE WAS THE RESULT OF USER-ERROR. THE DEVICE WAS RETURNED IN THE TIP WAS CONFIRMED TO BE BROKEN. THE DHR FOR THE BATCH OF THIS DEVICE WAS REVIEWED AND NO DEVIATIONS WERE REPORTED. THE SURGICAL TECHNIQUE STATES, "WHILE THE REVISION DRIVER IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED, AS IT CAN CAUSE BENDING OR BREAKAGE OF THE INNER SHAFT". IN THIS CASE THERE WAS NO PATIENT INVOLVEMENT. CONCLUSION: PREVIOUS INSTRUMENT FAILURES HAVE OCCURRED DUE TO USER-ERROR AND IT IS BELIEVED THAT IS THE CASE HERE AS WELL. THE SURGICAL TECHNIQUE STATES THAT PIVOTING OR ANGULATION OF THE INSTRUMENT MUST BE AVOIDED AS IT CAN LEAD TO BREAKING OF THE INNER SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "OUR TUCSON REPS QUITE [SIC] WORKING FOR STRYKER AND SHIPPED TRAYS BACK TO THE MAIN OFFICE IN PHOENIX. I RECEIVED THEM ON (B)(6) 2013 AND NOTICED THAT THERE WERE THREE INNER SHAFTS IN THE BOTTOM OF THE TRAY. TWO OF THEM WAS [SIC] BROKEN AND THE OTHER WAS POKING OUT OF ONE OF THE PERFORATED HOLES IN THE TRAY AND WAS BENT. I DO NOT KNOW IF THIS WAS DUE TO SHIPPING OR IF IT HAPPENED IN SURGERY. THIS IS ALL OF THE INFORMATION THAT I HAVE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93916 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR SCREW EXTRACTOR LXH STRYKER SPINE-FRANCE 094724

    Patients

    Seq Age Sex Outcome Treatment
    1