BEUDAMED
    FDA Adverse Event Injury Summary report: N

    10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE

    MDR report key: 4202081 · Received October 27, 2014

    Report

    Report Number
    1719045-2014-10542
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT HAD MULTIPLE FRACTURES TO INCLUDE LEFT ARM, RIGHT FEMUR AND RIGHT TIBIA. THE RIGHT FEMUR AND TIBIA WERE TREATED THROUGH THE SAME INCISION USING A TIBIAL NAIL FOR THE TIBIAL FRACTURE AND A RETROGRADE FEMORAL NAIL FOR THE FEMUR. THE TIBIA AT THIS TIME HAS HEALED AND THE PATIENT PRESENTS WITH A NONUNION OF THE FEMUR. THE SURGEON STATED IN RETROSPECT THE PATIENT PROBABLY SHOULD HAVE RECEIVED AN ANTEGRADE NAIL DUE TO THE PROXIMAL NATURE OF THE FRACTURE. ON (B)(6) 2014 THE RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) AND SCREWS WERE EXTRACTED AND ALL ITEMS WERE INTACT. THE FRACTURE WAS OPENED, THE NONUNION WAS CLEANED UP, PLATED WITH A SMALL FRAGMENT 8 HOLE LOCKING COMPRESSION PLATE (LCP) PLATE AND BONE GRAFTED USING CANCELLOUS CHIPS AND BONE MORPHOGENIC PROTEINS (BMP). THE FEMUR WAS REAMED IN THE APPROPRIATE FASHION AND A 12MM TROCHANTERIC FIXATION NAIL (TFN) WAS INSERTED WITH A 105MM LAG SCREW AND TWO DISTAL LOCKING SCREWS (42 &52MM). THE SURGERY WAS SUCCESSFULLY COMPLETED. AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: THERE ARE NOT DATES ON THE XRAYS ¿ BUT I CAN CONFIRM THAT THERE IS A FRACTURE THAT HAS BEEN TREATED WITH A NAIL AND THIS FRACTURE IS NOT HEALED. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684328 10MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/400MM-STERILE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES MONUMENT 5354854

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention