BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRA

    MDR report key: 2193170 · Received July 21, 2011

    Report

    Report Number
    9617544-2011-00256
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MFG RECORD REV., RISK ASSESSMENT AND VISUAL INSPECTION. RESULT: COMPLAINT HISTORY ANALYSIS, 44 PREVIOUS COMPLAINTS WITH THIS INSTRUMENT, WHICH IS WITHIN THE PREDICTED FAILURE OCCURRENCE RATE. PREVIOUS COMPLAINTS HAVE CONCLUDED THE FAILURES WERE THE RESULT OF USER ERROR. MFG RECORD REV., NO DISCREPANCIES FOUND THAT COULD BE RELATED TO THIS ISSUE. RISK ASSESSMENT, NO ADVERSE CONSEQUENCES TO THE PT. THE DRAW ROD IS MADE OF BIOCOMPATIBLE STAINLESS STEEL TO MITIGATE THE RISK OF BROKEN TIPS TO THE PT. VISUAL INSPECTION, INSTRUMENT TIP CONFIRMED AS BROKEN. CONCLUSION: A CHANGE OF MATERIAL TO BIOCOMPATIBLE TYPE 316VLM STAINLESS STEEL WAS MADE TO MITIGATE RISK OF BROKEN TIP REMAINING INSIDE PT, EFFECTIVE (B)(6), 2010. MOST PROBABLE CAUSE OF AN INNER SHAFT BREAKAGE OR BENDING IS THE INSTRUMENT NOT BEING USED PROPERLY. IT IS NOTED IN THE SURGICAL TECHNIQUE THAT WHILE THE SCREW EXTRACTOR IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT SHOULD BE AVOIDED, AS IT CAN CAUSE BENDING OR BREAKAGE OF THE INNER SHAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DRAW ROD BROKE DURING ATTEMPTED REVISION OF HYBRID SCREWS USING THE REVISION DRIVER. BROKE WHILE SURGEON WAS THREADING THE DRAW ROD INTO THE SCREW."

    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 100799

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK