BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGN IM NAIL

    MDR report key: 5915523 · Received August 30, 2016

    Report

    Report Number
    3034525-2016-00246
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Report Date
    August 25, 2016
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    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 LOCKING BOLT IS UNDETERMINED. SIGN FRACTURE CARE INTERNATIONAL WILL CONTINUE TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2016, THAT A SIGN LOCKING BOLT WAS BROKEN. NO CASE OR CAUSE DATA PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565896 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR