BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END-CAP F/A2FN CANN EXTENS. 0 TAN GREY

    MDR report key: 3026765 · Received March 29, 2013

    Report

    Report Number
    8030965-2013-01208
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: JDS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING A PROCEDURE TO PLACE A NAIL, THE SURGEON THREADED A GUIDE WIRE INTO THE PATIENT AND INSERTED THE END CAP WITH A SCREWDRIVER. THE SURGEON DID NOT NOTICE THAT THE GUIDE WIRE WAS IN THE CANAL BUT OUTSIDE THE NAIL. AND THE END CAP ENTERED THE CANAL. THE SURGEON WAS UNABLE TO RETRIEVE THE END CAP AND LEFT IT IN PLACE IN THE FEMORAL CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131043 END-CAP F/A2FN CANN EXTENS. 0 TAN GREY HSB SYNTHES GMBH 8058828

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention