BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 2962293 · Received February 14, 2013

    Report

    Report Number
    0009617544-2013-00028
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION. DEVICE NOT AVAILIBLE.

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION COULD NOT BE PERFORMED DUE TO THE UNAVAILABILITY OF THE IMPLICATED INSTRUMENT. THE RELEVANT MANUFACTURING DOCUMENTATION COULD NOT BE REVIEWED AS THE BATCH NUMBER OF THE IMPLICATED INSTRUMENT WAS UNKNOWN. THE REPORTED EVENT IS STRONGLY SUSPECTED TO RELATE TO THE BREAKAGE OF THE DISTAL TIP OF THE REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT. THE BREAKAGE IS BELIEVED TO BE THE RESULT OF USER- ERROR. THE REFLEX-HYBRID SURGICAL TECHNIQUE STATES THAT "WHILE THE SCREW EXTRACTOR IS ATTACHED TO THE SCREW, PIVOTING OR ANGULATION OF THE INSTRUMENT SHOULD BE AVOIDED, AS THIS CAN CAUSE BENDING OR BREAKING OF THE INNER SHAFT". THE SURGICAL TECHNIQUE ALSO STATES THAT "THE SCREW EXTRACTOR MUST BE AXIALLY ALIGNED WITH THE SCREW TRAJECTORY AND FULLY SEATED IN THE SCREW HEAD BEFORE INSERTING OR TIGHTENING THE INNER SHAFT". EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. THE RATE OF FAILURE AND RELATED SEVERITIES ARE WITHIN THRESHOLDS LEVELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE VERY TIP OF THE DRAW ROD WAS BROKEN OFF SO THAT A PORTION OF THE THREADED TIP WAS MISSING."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE VERY TIP OF THE DRAW ROD WAS BROKEN OFF SO THAT A PORTION OF THE THREADED TIP WAS MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64282 REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT INSTRUMENT LXH STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1