BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGN IM NAIL

    MDR report key: 5389811 · Received January 25, 2016

    Report

    Report Number
    3034525-2016-00013
    Event Type
    Malfunction
    Date Received
    January 25, 2016
    Date of Event
    February 8, 2016
    Report Date
    February 16, 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
    NG
    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 IS UNDETERMINED BUT ASSUMED TO BE PROXIMITY OF THE FRACTURE TO THE DISTAL END OF THE IMPLANT. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. CORRECTIVE SURGERY HAS BEEN COMPLETED. 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 02/10/2016, THAT A SIGN IM NAIL IMPLANTED TO REPAIR A FRACTURE OF THE LEFT TIBIA, PREVIOUSLY REPORTED AS HAVING BEEN FOUND TO BE BROKEN DURING A FOLLOW UP VISIT, HAS NOW BEEN EXCHANGED. THIS COMPLAINT WAS SUBMITTED TO THE FDA UNDER MFR # 3034525-2016-00013, (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47963 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization