BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 6233308 · Received January 9, 2017

    Report

    Report Number
    3034525-2017-00001
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    January 5, 2017
    Report Date
    January 12, 2017
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AF
    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 NAIL AND SCREW IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. CORRECTIVE SURGERY HAS NOT BEEN SCHEDULED AS OF THIS DATE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES. A FOLLOW UP REPORT WILL BE FILED WHEN WE RECEIVE NEW INFORMATION REGARDING THIS CASE.

    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 AND BROKEN NAIL 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 ACTIVITIES.

    Description of Event or Problem · 1

    WE BECAME AWARE (B)(6) 2017, IT WAS REPORTED THAT A SIGN IM NAIL AND SCREW IMPLANTED TO REPAIR A FRACTURE WAS FOUND TO BE BROKEN DURING A FOLLOW UP VISIT.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2017 SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS EXCHANGED. THE IM NAIL WAS PREVIOUSLY REPORTED TO THE FDA AS BROKEN ON (B)(6) 2017, WITH THE PATIENT IDENTIFIER (B)(6). THE BROKEN IM NAIL WAS REPLACED WITH A 10MM X 380MM STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16716 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| R