BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 17557987 · Received August 16, 2023

    Report

    Report Number
    3034525-2023-00150
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    September 11, 2023
    Report Date
    November 9, 2023
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Product Problem
    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 BROKEN NAIL IS UNDETERMINED BUT SUSPECTED TO BE CAUSED BY FATIGUE FROM NON-UNION. 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 WITH THIS TYPE OF FAILURE 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 ACTIVITIES.

    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 BROKEN NAIL IS UNDETERMINED BUT SUSPECTED TO BE CAUSED BY FATIGUE FROM NON-UNION. 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. THE RISK ASSOCIATED WITH THIS TYPE OF FAILURE 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 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 FOUND TO BE BROKEN DURING A FOLLOW UP VISIT. SURGEON COMMENT: "NONUNION OF FRACTURE SITE, BOOKED FOR REPLACEMENT OF NAIL AND BONE GRAFTING."

    Description of Event or Problem · 0

    WE BECAME AWARE ON 11/09/2023 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS EXCHANGED. THE IM NAIL WAS PREVIOUSLY REPORTED TO THE FDA AS BROKEN ON (B)(6) 2023, WITH THE PATIENT IDENTIFIER 170808. THE BROKEN IM NAIL WAS REPLACED WITH A 11MM X 400MM STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895859 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization| R