BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 5894751 · Received August 22, 2016

    Report

    Report Number
    3034525-2016-00233
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    September 25, 2016
    Report Date
    January 19, 2017
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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.

    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 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.

    Description of Event or Problem · 1

    WE BECAME AWARE ON 1/19/2017 THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS EXCHANGED DUE TO A NON-UNION AND A BROKEN NAIL. THE BROKEN IM NAIL WAS REPORTED TO THE FDA ON (B)(4) 2016, WITH PATIENT IDENTIFIER (B)(6). THE BROKEN IM NAIL WAS REPLACED WITH A 9MM X 380MM STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2016, IT WAS REPORTED THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE WAS FOUND TO BE BROKEN DURING A FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547113 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R