BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATIC NAVIGATOR INSERTER

    MDR report key: 2945650 · Received February 6, 2013

    Report

    Report Number
    0009617544-2013-00014
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY, AND RISK ANALYSIS. RESULTS: VISUAL INSPECTION: THE VISUAL INSPECTION CONFIRMED THAT THE STRAIGHT MAIN SHAFT IS SLIDING INTO THE HANDLE. THE WELD WHICH ONCE UNITED THE HANDLE PART OF THE INSTRUMENT AND THE STRAIGHT MAIN SHAFT IS BROKEN. THE EXAMINATION OF THE BROKEN WELD EVIDENCED A THIN PORTION OF MELTED METAL. DEVICE HISTORY REVIEW: THE REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY RELEVANT DEVIATION WHICH COULD HAVE LED TO THE DAMAGE REPORTED. ALL THE PARTS AND THEIR SUB-COMPONENTS WERE INDIVIDUALLY INSPECTED AND WERE CONFORMING TO THE SPECIFICATION. COMPLAINT HISTORY: A TOTAL OF 40 COMPLAINTS INVOLVING 40 UNITS HAVE BEEN RECEIVED FOR THE REGULAR STRAIGHT INSERTER AND THE CUSTOM-MADE ONE. RISK ANALYSIS: IT IS NOT FEASIBLE TO DETERMINE THE ACTUAL OCCURRENCE RATE WITH THE CUSTOM-MADE STRAIGHT INSERTER AS THE IMPLANT SALES FIGURES DO NOT DISTINGUISH THE CAGES THAT HAVE BEEN IMPLANTED WITH THE REGULAR SET OF INSTRUMENTS AND THE CUSTOM-MADE INSERTER. CONCLUSION: THE EXAMINATION OF THE DEVICE RETURNED CONFIRMED THAT IT IS BROKEN AT THE LEVEL OF THE WELD JOINING THE HANDLE TO THE STRAIGHT MAIN SHAFT. THE STRAIGHT INSERTER IS INTENDED TO LOCK THE NAVIGATOR CAGE SO THAT THE SURGEON CAN INTRODUCE IT INTO THE DISC SPACE. THE CAGE IS SECURED TO THE INSERTER THANKS TO THE DISPLACEMENT OF THE LOCK SHAFT ASSEMBLY WHICH IS ACTIVATED BY THE ROTATION OF THE LOCKING KNOB AT THE EXTREMITY OF THE HANDLE. WHEN THE CAGE IS PRESENT AT THE EXTREMITY OF THE INSERTER AND THE LOCKING KNOB IS TURNED TO TIGHTEN THE CAGE, THERE IS TENSILE AND SHEAR STRESS APPLIED TO THE WELD JOINING THE HANDLE TO THE STRAIGHT MAIN SHAFT. DUE TO THE FINE PITCH OF THE THREAD WITHIN THE LOCKING KNOB (2 X 0,6MM PER TURN), THE FORCE TENDING TO PULL THE STRAIGHT MAIN SHAFT OUT OF THE HANDLE CAN BE APPLIED VERY PROGRESSIVELY WITH LIMITED EFFORT FROM THE USER, AND AS A CONSEQUENCE, THE FORCE CAN BE SIGNIFICANT, RESULTING IN HIGH STRESS WITHIN THE WELD, ESPECIALLY IF THE WELD IS WEAK. THE ASSEMBLY METHOD AND/OR THE WELDING PROCESS BETWEEN THE HANDLE AND THE STRAIGHT MAIN SHAFT SEEMS TO BE SUB-OPTIMAL WHEN CONSIDERING THE FORCES ACTING ON THE WELD DURING THE NORMAL USE OF THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NAVIGATOR STATIC HANDLE FELL APART IN DECONTAMINATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NAVIGATOR STATIC HANDLE FELL APART IN DECONTAMINATION "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50782 STATIC NAVIGATOR INSERTER INSTRUMENT LXH STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1