BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 4836835 · Received June 10, 2015

    Report

    Report Number
    3034525-2015-00092
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    August 12, 2016
    Report Date
    August 18, 2016
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE LOOSENED SCREW IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. AT THE TIME OF THE FOLLOW UP VISIT THE X-RAYS SHOWED THAT THE FRACTURE WAS HEALED. THE LOOSE SCREW WAS LEFT IN PLACE AND PRESENTS NO RISK OF INJURY OR DEATH FOR THE PATIENT. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Additional Manufacturer Narrative · 1

    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. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THERE IS NO WAY TO PREDICT A NON-UNION OR FAILURE TO HEAL. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 1

    WE BECAME AWARE ON 8/18/2016 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS REPLACED DUE TO A NON-UNION. THE IM NAIL WAS REPLACED WITH A 10MM X 380MM, STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015, THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURED LEFT FEMUR; WAS SHOWN TO HAVE A LOOSE PROXIMAL SCREW DURING A FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375998 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R