BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 12594602 · Received October 7, 2021

    Report

    Report Number
    3034525-2021-00147
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 13, 2021
    Report Date
    September 27, 2021
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    PHYSICIAN

    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) 2021 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 9MM X 340MM STANDARD IM NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "PATIENT HAD AN INFECTED BONE IMPLANT FAILURE WITH EXPOSED DESICCATED TIBIA BONE FRAGMENT, DISCHARGE OF PURULENT EFFLUENT WITH MULTIPLE PYOGENIC MEMBRANES. HE HAD THE FOLLOWING DONE. 1 REMOVAL OF IMPLANT 2. RESECTION OF NECROTIC BONE SEGMENT 3. REAMING TO REMOVE PYOGENIC MEMBRANE 4. EXCHANGE OF SIGN NAIL 5. GENTAMICIN BONE CEMENT TO FILL THE DEFECT 6. FLAP ROTATION BY PLASTIC SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485672 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R