BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT

    MDR report key: 3969461 · Received July 31, 2014

    Report

    Report Number
    0009617544-2014-00335
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE INSTRUMENT FRACTURE MAY A RESULT OF OVER TIGHTENING. EXCESSIVE TIGHTENING COULD ALSO RESULT IN THE DEFORMATION OF THE INSTRUMENT DISTAL TIP. NO MANUFACTURING ISSUES WERE FOUND FOR THIS LOT NUMBER. CONCLUSION: THE LIKELY MODE WAS TORSIONAL OVERLOAD AS EXAMINED VISUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUR SPINE MGR. WAS ATTEMPTING TO REMOVE A SCREW FROM A PLATE WHILE TESTING SYSTEM BEFORE SENDING TO A CASE, WHILE ATTEMPTING TO REMOVE SCREW, THE DRAW ROD SNAPPED. WE PLACED NOTE ON THE DRAW ROD TO INSURE IT WAS PULLED FROM SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OUR SPINE MGR. WAS ATTEMPTING TO REMOVE A SCREW FROM A PLATE WHILE TESTING SYSTEM BEFORE SENDING TO A CASE, WHILE ATTEMPTING TO REMOVE SCREW, THE DRAW ROD SNAPPED. WE PLACED NOTE ON THE DRAW ROD TO INSURE IT WAS PULLED FROM SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446719 REFLEX HYBRID SCREW EXTRACTOR INNER SHAFT INSTUMENT-EXTRACTOR LXH STRYKER SPINE-FRANCE 11E012

    Patients

    Seq Age Sex Outcome Treatment
    1