BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGN IM NAIL

    MDR report key: 5488164 · Received March 8, 2016

    Report

    Report Number
    3034525-2016-00061
    Event Type
    Malfunction
    Date Received
    March 8, 2016
    Report Date
    March 1, 2016
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CG
    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 TIP 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 SIGN LOCKING BOLT TIP WAS BROKEN DURING INSERTION. NO CAUSE DATA PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141815 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR