BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEX STARDRIVE SCREWDRIVER

    MDR report key: 3003379 · Received February 28, 2013

    Report

    Report Number
    2530088-2013-10200
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    May 30, 2011
    Report Date
    June 1, 2011
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. VISUAL EVALUATION NOTED THE TIP OF THE HEX DRIVE HAS SHEARED OFF AT AN ANGLE, AND THE BROKEN PIECE WAS NOT RETURNED. PHYSICAL DIMENSIONAL VERIFICATION OF THE HEX TIP WAS FOUND IMPOSSIBLE DUE TO THE DAMAGE EXHIBITED BY THE INSTRUMENT. ALL OTHER FEATURES RELATED TO THIS COMPLAINT THAT COULD BE VERIFIED DURING THE MANUFACTURING INVESTIGATION MET SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE SURGERY ON HARDWARE REMOVAL THE TIP OF THE SCREWDRIVER BROKE OFF/ BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. THIS INCIDENT ADDED ABOUT 10 MINUTES TO THE SURGERY TIME, AS SURGEON NEEDED TO GET ANOTHER SCREWDRIVER. THIS WAS A SCHEDULED REVISION FOR REMOVAL OF NAIL AND HARDWARE FOR CONVERSION TO A TOTAL KNEE REPLACEMENT ON (B)(6) 2011. THE SURGEON REMOVED THE NAIL BECAUSE IT WOULD HAVE INTERFERED WITH THE KNEE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86655 HEX STARDRIVE SCREWDRIVER HXX SYNTHES (USA) BRANDYWINE 5489717

    Patients

    Seq Age Sex Outcome Treatment
    1