BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 5095920 · Received September 22, 2015

    Report

    Report Number
    3034525-2015-00171
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    October 22, 2015
    Report Date
    October 30, 2015
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE BROKEN NAIL AND SCREW IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THE FIRST IM NAIL WAS REPLACED WITH A 10MM X 320MM, STANDARD NAIL USING TWO PROXIMAL SCREWS AND TWO DISTAL SCREWS. 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 DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE BROKEN NAIL AND SCREW IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THE ATTENDING SURGEON INDICATED A REPEAT SURGERY FOR THE BROKEN IM NAIL WAS NEEDED. A FOLLOW UP REPORT WILL BE FILED WHEN WE RECEIVE NEW INFORMATION. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015 THAT AN IM NAIL USED TO REPAIR A FRACTURE OF THE LEFT TIBIA, HAD BEEN BROKEN AND WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2015, THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE OF THE LEFT TIBIA; DURING X-RAY REVIEW WAS FOUND TO BE BROKEN ALONG WITH ONE PROXIMAL SCREW DURING A FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624600 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R