BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 3953939 · Received July 23, 2014

    Report

    Report Number
    0009617544-2014-00321
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE REPORTED REFLEX HYBRID REVISION DRIVER SCREW EXTRACTOR WAS CONFIRMED VISUALLY TO HAVE THE DISTAL THREADED TIP BROKEN OFF DURING SURGERY. NO MANUFACTURING ISSUES WERE FOUND FOR THIS LOT NUMBER. THE INSTRUMENT FRACTURE MAY A RESULT OF OVER TIGHTENING. EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. IT HAS BEEN ACKNOWLEDGED THAT BREAKAGES OF THE INSTRUMENT DISTAL TIP WILL OCCUR DUE TO THE NATURE OF REVISION SURGERY AS WELL AS THE SMALL DRAW ROD DIAMETER REQUIRED TO INTERFACE WITH A SCREW IN THE CERVICAL SPINE. THERE WAS ALSO A FIELD BULLETIN ISSUED IN 2009 ADDRESSING THIS AND THE REFLEX-HYBRID REVISION DRIVER DRAW ROD TIP IS NOW MADE FROM BIOCOMPATIBLE MATERIAL TO MITIGATE THE RISK OF IT REMAINING IN A POTENTIAL PATIENT. THE CAUSE IS NOT DETERMINED, MULTI-FACTORIAL. CONCLUSION: THE LIKELY MODE WAS TORSIONAL OVERLOAD AS EXAMINED VISUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REFLEX HYBRID REVISION DRIVER INNER DRAW ROD SNAPPED WHILE REMOVING THE BONE SCREW FROM THE REFLEX HYBRID PLATE DURING A ONE LEVEL PLATE REMOVAL. THE SURGEON THEN WAS ABLE TO USE THE STANDARD SCREW DRIVER TO REMOVE THE REST OF THE SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REFLEX HYBRID REVISION DRIVER INNER DRAW ROD SNAPPED WHILE REMOVING THE BONE SCREW FROM THE REFLEX HYBRID PLATE DURING A ONE LEVEL PLATE REMOVAL. THE SURGEON THEN WAS ABLE TO USE THE STANDARD SCREW DRIVER TO REMOVE THE REST OF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431843 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR INSTRUMENT-SCREW EXTRACTOR LXH STRYKER SPINE-FRANCE 137401

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR