BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL SCREWDRIVER

    MDR report key: 759759 · Received September 13, 2006

    Report

    Report Number
    9615741-2006-00026
    Event Type
    Injury
    Date Received
    September 13, 2006
    Report Date
    September 8, 2006
    Manufacturer
    NEWDEAL S.A.
    Product Code
    KXX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE ORTHOPEDIC FOOT AND ANKLE SPECIALIST PHYSICIAN PERFORMED AN ARTHRODESIS IN 2006, USING THE KALIX SET. WHEN HE TRIED USING THE INTERNAL SCREWDRIVER (PRODUCT ID #119-840), IT WOULD NOT FUNCTION PROPERLY. THE PHYSICIAN NOTED THAT THE DISTAL END OF THE DEVICE APPEARS TO HAVE SHEARED OFF. THE SCREWDRIVER COULD NOT SEAT PROPERLY WITHIN THE IMPLANT AND ALLOW THE SURGEON TO EXPAND THE ARTHRODESIS. THE PHYSICIAN TRIED TO GET IT TO WORK BY REMOVING THE EXTERNAL SCREWDRIVER SO THAT HE WOULD HAVE EASIER ACCESS TO THE IMPLANT AND VISUAL IDENTIFICATION. THIS ATTEMPT FORCED THE METALLIC PART OF THE IMPLANT ALL THE WAY THROUGH THE IMPLANT. THE PHYSICIAN WAS ABLE TO REMOVE ALL PIECES OF THE 11MM IMPLANT (PRODUCT ID #140-011). THE PHYSICIAN THEN TRIED TO SALVAGE THE PROCEDURE BY USING A FREE-ER, AND THE UNSCREWER FROM THE KALIX SET. THE PHYSICIAN USED A NEW 11MM IMPLANT TO COMPLETE THE SURGERY. THE REVISION WORKED AND THE PHYSICIAN WAS SATISFIED WITH THE END RESULT THAT HE ACHIEVED. THE KALIX SET IS AVAILABLE FOR RETURN AND EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL SCREWDRIVER KALIX ASSOCIATED INSTRUMENTS KXX NEWDEAL S.A. * D2TR

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention