BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGN IM NAIL

    MDR report key: 5737259 · Received June 20, 2016

    Report

    Report Number
    3034525-2016-00188
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    June 14, 2016
    Report Date
    December 8, 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
    MG
    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 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.

    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 6/16/2016 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 300MM, STANDARD NAIL PER THE SIGN TECHNIQUE MANUAL. SURGEON COMMENT: "WE DONE SYNTHETIC BONEGRAFT OSTEON II."

    Description of Event or Problem · 1

    WE BECAME AWARE ON 12/08/2016, 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
    389971 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| R