BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE OSTEOTOME CURVED

    MDR report key: 3403028 · Received October 10, 2013

    Report

    Report Number
    0009617544-2013-00410
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 13, 2013
    Report Date
    September 16, 2013
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; DEVICE INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE RELIANCE OSTEOTOME STRAIGHT WAS CONFIRMED TO HAVE A DEFORMED TIP UPON VISUAL INSPECTION. THE MANUFACTURING RECORDS WERE REVIEWED FOR LOT # 116834 AND THERE WERE NO RELEVANT ISSUES FOUND DURING THE MANUFACTURING PROCESS. THIS EVENT OCCURRED INTRA-OP BUT DID NOT RESULT IN ANY SURGICAL DELAY OR ADVERSE CONSEQUENCES FOR THE PATIENT. THE ROOT CAUSE FOR THIS EVENT IS MOST LIKELY DUE TO MISUSE OF THE INSTRUMENT, IN ADDITION TO A DESIGN ISSUE REGARDING A CHANGE IN THE RAW MATERIAL OF THE OSTEOTOME WHICH WAS CORRECTED IN CAPA 2010-081. AT THIS TIME, THE EXACT CAUSE CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL IN NATURE. CONCLUSION: THE ROOT CAUSE FOR THIS EVENT IS MOST LIKELY DUE TO MISUSE OF THE INSTRUMENT, IN ADDITION TO A DESIGN ISSUE REGARDING A CHANGE IN THE RAW MATERIAL OF THE OSTEOTOME WHICH WAS CORRECTED IN (B)(4). AT THIS TIME, THE EXACT CAUSE CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL IN NATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DAMAGED THE STRYKER OSTEOTOMES ON VERY HARD PATIENT BONE. THEY USED OTHER HOSPITAL ISSUED OSTEOTOMES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON DAMANGED THE STRYKER OSTEOTOMES ON VERY HARD PATIENT BONE. THEY USED OTHER HOSPITAL ISSUED OSTEOTOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521175 RELIANCE OSTEOTOME CURVED INSTRUMENT LXH STRYKER SPINE-FRANCE 116834

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR