BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGN IM NAIL

    MDR report key: 5820153 · Received July 25, 2016

    Report

    Report Number
    3034525-2016-00208
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    March 12, 2016
    Report Date
    July 21, 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 DRILL BIT IS UNDETERMINED BUT SUSPECT USER MISUSE. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. THE BROKEN DRILL BIT PRESENTS NO RISK OF INJURY OR DEATH TO THE PATIENT AND WAS LEFT IN PLACE. SIGN FRACTURE CARE INTERNATIONAL CONTINUES 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 DURING AN IM NAIL IMPLANT SURGERY TO REPAIR A FRACTURE THAT A DRILL BIT BROKE AND WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472843 SIGN IM NAIL INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR