BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVIATOR QUICK TURN SCREWDRIVER

    MDR report key: 2121994 · Received May 24, 2011

    Report

    Report Number
    9617544-2011-00184
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION, COMPLAINT HISTORY ANALYSIS, MANUFACTURING RECORD REVIEW, RISK REVIEW. RESULT: VISUAL INSPECTION CONFIRMS REPORTED EVENT, BROKEN FRAGMENT WAS NOT RETURNED. COMPLAINT HISTORY ANALYSIS - THIS IS THE 2ND COMPLAINT OF THIS NATURE FOR THIS PRODUCT. MANUFACTURING RECORD REVIEW - MANUFACTURING RECORDS WERE REVIEWED, NO DEVIATIONS WERE REPORTED. RISK REVIEW - BROKEN PART IS EASILY NOTICEABLE, COULD FALL IN THE WOUND BUT WOULD ONLY REQUIRE LIMITED ADDITIONAL TIME TO RETRIEVE IT. WORST CASE SCENARIO WHERE NOT DETECTED BY SURGEON, IT WOULD BE VISIBLE ON X-RAYS TO INDICATE NEED FOR REMOVAL. CONCLUSION: VISUAL INSPECTION CONFIRMED THE REPORTED EVENT. THE DEFECT IS BELIEVED TO BE THE RESULT OF EXCESSIVE CANTILEVER FORCES BEING APPLIED TO THE INSTRUMENT BY THE SURGEON. (B)(4) WAS INITIATED TO DOCUMENT ALL ACTIONS TAKEN TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A CERVICAL FUSION CASE, THE DOCTOR WAS PLACING A SCREW AND THE TIP OF THE SCREWDRIVER BROKE OFF. THE INNER DRAW ROD WAS NOT AFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR QUICK TURN SCREWDRIVER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 103988

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK