BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS

    MDR report key: 2944929 · Received February 1, 2013

    Report

    Report Number
    2530088-2013-10040
    Event Type
    Injury
    Date Received
    February 1, 2013
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MFG REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TFN PROCEDURE, THE SURGEON NOTED THE INSERTION HANDLE (P/N 357.411) WAS NOT LINING UP WITH THE HOLE IN THE TFN NAIL (P/N (B)(4)). THE SURGEON REMOVED THE ARM OF THE INSERTION HANDLE AND INSERTED THE DISTAL LOCKING SCREW (P/N (B)(4)) BY HAND. THE PROCEDURE WAS COMPLETED; HOWEVER, IT TOOK AN ADDITIONAL 15 MINUTES TO COMPLETE THE PROCEDURE. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43960 INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS FZX SYNTHES (USA) MONUMENT 4785844

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention