BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 20048203 · Received August 23, 2024

    Report

    Report Number
    3034525-2024-00149
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 8, 2024
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE NON-UNION IS UNDETERMINED. THERE IS NO WAY TO PREDICT A NON-UNION OR FAILURE TO HEAL. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THIS FAILURE DOES NOT INDICATE A DEFECT IN THE PRODUCT. A MINIMAL RISK IS ASSOCIATED WITH THIS FAILURE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILANCE ACTIVITIES.

    Description of Event or Problem · 0

    WE BECAME AWARE ON (B)(6)2024 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS REPLACED DUE TO A NON-UNION. THE IM NAIL WAS REPLACED WITH A 12MM X 340MM STANDARD IM NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "-GENEROUS ILIAC BONE GRAFT TO FRACTURE - SEVERELY OSTEOPOROTIC DISTAL TIB WOULD NOT HOLD SCREWS - #1 PDS CERCLAGE X 4 AROUND BUTTERFLY FRAGMENT + IBG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581919 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H