BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID SCREW EXTRACTOR

    MDR report key: 4400059 · Received January 8, 2015

    Report

    Report Number
    0009617544-2015-00014
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 11, 2014
    Report Date
    December 11, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED/CORRECTED LOT CODE TO LOT # 130936. METHOD: DEVICE EVALUATION, MATERIAL ANALYSIS AND DEVICE HISTORY REVIEW. RESULTS: MANUFACTURING FILES WERE REVIEWED AND NO ISSUES WERE FOUND FOR THIS LOT NUMBER. VISUAL INSPECTION INDICATED THE RETURNED INSTRUMENTS WERE VISUALLY INSPECTED AND THE CRUCIFORMS ON EACH WERE CONFIRMED TO BE SHEARED OFF. THE REMOVABLE DRAW ROD WAS NOT RETURNED AS IT WAS NOT FRACTURED. MATERIAL ANALYSIS INDICATED THE CRUCIFORMS OF EACH OF THE SUBMITTED SCREW EXTRACTORS WERE FOUND TO HAVE FRACTURED IN A DUCTILE OVERLOAD MODE RESULTING FROM THE TORSIONAL FORCE APPLIED TO THE SCREWDRIVER. NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND. CONCLUSION: THE INSTRUMENT DEFORMATION LIKELY RESULTED FROM THE HIGH AMOUNT OF TORQUE REQUIRED TO REMOVE THE SCREWS THAT WHERE PLACED IN THE DISEASED BONE (BONE QUALITY ) AND BONY GROWTH AROUND THE IMPLANTED SCREWS. THE PROBABLE ROOT CAUSE IS PATIENT RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A REMOVAL AND TRYING TO REMOVE THE SCREWS THE TOP OF BOTH SCREWDRIVERS SNAPPED OFF. THERE WAS NOT MUCH OF A DELAY AS A THIRD REMOVAL DRIVER THAT WAS ABLE TO GET THE SCREW OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A REMOVAL AND TRYING TO REMOVE THE SCREWS THE TOP OF BOTH SCREWDRIVERS SNAPPED OFF. THERE WAS NOT MUCH OF A DELAY AS A THIRD REMOVAL DRIVER THAT WAS ABLE TO GET THE SCREW OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16073 REFLEX-HYBRID SCREW EXTRACTOR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER SPINE-FRANCE 130936

    Patients

    Seq Age Sex Outcome Treatment
    1