BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2241090 · Received August 17, 2011

    Report

    Report Number
    9617544-2011-00286
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS AND RISK ASSESSMENT. RESULTS: COMPLAINT HISTORY ANALYSIS. THERE HAVE BEEN 51 TOTAL COMPLAINTS RELATED TO DRAW ROD TIP DEFORMATION; THOSE INVESTIGATIONS CONCLUDED THAT USER-ERROR LEAD TO THE FAILURES. RISK ASSESSMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. THERE ARE OTHER INSTRUMENTS IN THE KIT THAT CAN BE USED FOR SCREW EXTRACTION, SO ANY PROLONGATION OF THE SURGERY IS MINIMAL. ALSO, THE DRAW ROD IS MADE OF A BIOCOMPATIBLE STAINLESS STEEL IN CASE THE BROKEN TIP REMAINS INSIDE THE PT. CONCLUSION: THE IMPLICATED INSTRUMENT WAS NOT RETURNED, SO A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. PREVIOUS INSTRUMENT FAILURES HAVE OCCURRED DUE TO USER-ERROR AND IT IS BELIEVED THAT IS ALSO THE CASE HERE. THE SURGICAL TECHNIQUE STATES THAT PIVOTING AND ANGULATION MUST BE AVOIDED AS IT CAN LEAD TO BREAKING OF THE INNER SHAFT. IT ALSO STATES THAT THE REVISION DRIVER SHOULD NOT BE USED AS AN INSERTION DRIVER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR. (B)(6) WAS USING THE REMOVAL DRIVER FOR THE HYBRID REFLEX AND THE TIP OF THE INNER SHAFT BROKE OFF INTO THE SCREW HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA INSTRUMENT LXH STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK