BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 5676852 · Received May 24, 2016

    Report

    Report Number
    3034525-2016-00138
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 21, 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 BROKEN SCREW IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THE BROKEN SCREW PRESENTS NO RISK OF INJURY OR DEATH TO THE PATIENT AND WAS LEFT IN PLACE. 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 (B)(6) 2016, THAT A SIGN NAIL IMPLANTED TO REPAIR A FRACTURE SHOWED A BROKEN SCREW IN THE X-RAYS TAKEN DURING A FOLLOW UP VISIT.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 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 11MM X 380MM, STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330130 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R