BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 17694846 · Received September 6, 2023

    Report

    Report Number
    3034525-2023-00165
    Event Type
    Injury
    Date Received
    September 6, 2023
    Date of Event
    August 1, 2023
    Report Date
    August 18, 2023
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KE
    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 ROOT CAUSE OF THE INFECTION IS UNDETERMINED. INFECTIONS HAVE MANY CAUSES AND TREATMENTS. EACH INFECTION IS ADDRESSED INDIVIDUALLY AND TAKEN VERY SERIOUSLY BY BOTH THE ATTENDING SURGEON AND SIGN SURGEONS AT SIGN HEADQUARTERS. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THIS FAILURE DOES NOT INDICATE A DEFECT IN THE PRODUCT. THE RISK ASSOCIATED WAS EVALUATED DURING THE RISK MANAGEMENT PROCESS AND WAS DEEMED AN ACCEPTABLE LEVEL OF RISK TO THE PATIENT. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    WE BECAME AWARE ON (B)(6) 2023 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS REPLACED DUE TO A NON-UNION WITH INFECTION. THE IM NAIL WAS REPLACED WITH A 12MM X 360MM STANDARD IM NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "AFTER RIGHT TIBIA SIGN + FLAP FOR GIIIB TIB/FIB FX COMPLICATED BY OSTEOMYELITIS. POST HWR + ABX NAIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122555 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Hospitalization| R