BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS CANN CONNECTING SCREW F/TROCH FIXATION NAILS

    MDR report key: 3022260 · Received March 26, 2013

    Report

    Report Number
    2520274-2013-01704
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A TFN PROCEDURE ON (B)(6) 2013, AS SURGEON WAS INSERTING THE HELICAL BLADE INTO THE NAIL, THE BLADE STOPPED. X-RAYS SHOWED THAT THE BLADE WAS HITTING THE WRONG PORTION OF THE NAIL. THE BLADE WOULD NOT GO INTO THE CENTER HOLE OF THE NAIL. ALSO, WHEN SURGEON ATTEMPTED TO REMOVE THE NAIL, THE NAIL WOULD NOT DISENGAGE FROM THE AIMING ARM. AT THAT POINT, THE SURGEON REMOVED ALL HARDWARE AND STARTED OVER WHAT A NEW SET OF INSTRUMENTS AND IMPLANTS. THIS ISSUE CAUSED SURGERY TO EXTEND AN ADDITIONAL 20 MINUTES. THIS IS 7 OF 8 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124442 PERCUTANEOUS CANN CONNECTING SCREW F/TROCH FIXATION NAILS LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention