BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 2182603 · Received July 5, 2011

    Report

    Report Number
    9617544-2011-00229
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY ANALYSIS, MFG RECORD REV., RISK ASSESSMENT REVIEW AND VISUAL INSPECTION. RESULT: COMPLAINT HISTORY ANALYSIS: 24 COMPLAINTS FOR TIP BREAKAGE. MFG RECORD REVIEW: NO DISCREPANCIES FOUND THAT COULD BE RELATED TO THIS ISSUE. VISUAL INSPECTION: CONFIRMED BROKEN, INSTRUMENT SHAFT WAS ALSO SEVERELY BENT, TIP OF INSTRUMENT WAS NOT RETURNED. RISK ASSESSMENT: NO ADVERSE CONSEQUENCES TO THE PT AND THE BROKEN FRAGMENTS WERE SAFELY REMOVED FROM PT, CONFIRMED VIA X-RAY. 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 TIP 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 "REMOVING THREE LEVEL REFLEX HYBRID PLATE C4-7 (IMPLANTED (B)(6) 2007) INNER SHAFT OF REVISION DRIVER BROKE AND DAMAGED HEAD OF SCREW UPON REMOVAL (TWO OF THE PRONGS ON THE SCREW BROKE). SCREWS WERE REMOVED WITHOUT INNER SHAFT. PLATE WAS REMOVED AND NEW 1 LEVEL PLATE PUT ON FOR REVISION LEVEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 09C656

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK