BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 3143110 · Received May 29, 2013

    Report

    Report Number
    3034525-2013-00024
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 25, 2013
    Report Date
    May 28, 2013
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVIEWED SURGICAL DATABASE REPORT OF A BROKEN NAIL. REVIEW SURGEONS REPORT OF A BROKEN I'M NAIL DUE TO A NON-UNION. REVIEWED PATIENT X-RAYS WHICH SHOWED A SIGN NAIL BROKEN AT THE PROXIMAL DISTAL SLOT. IN ADDITION, IT SHOWED A DHS WITH ONE OF THE SCREWS PLACED SO AS TO APPLY PRESSURE AT THE DISTAL END OF THE NAIL. THE NON-UNION ALLOWED THE FRACTURE TO SHIFT AND APPLY MORE STRESS TO THE DISTAL END OF THE NAIL WHICH WAS IMMOVABLE DUE TO THE SCREW HOLDING IT IN PLACE AGAINST THE CORTEX. THE SURGEON PREFORMED AN EXCHANGE NAIL SURGERY TO REMOVE THE DHS, REPAIR THE FRACTURE AND REPLACE THE I'M NAIL. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235955 SIGN IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization