BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 2920091 · Received January 8, 2013

    Report

    Report Number
    3034525-2013-00002
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 8, 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

    DATABASE REPORT OF A BROKEN IM NAIL, THE SURGEON INDICATED AN EXCHANGE NAIL PROCEDURE TO CHANGE THE BROKEN 8MM NAIL FOR A 10MM NAIL. REVIEW OF THE PATIENT X-RAYS SHOWS A NAIL BROKEN AT ONE OF THE DISTAL SCREW SLOTS. THE X-RAYS ALSO SHOWED A NON-UNION WHICH APPEARS TO HAVE SHIFTED CAUSING STRESS AT THE DISTAL END OF THE NAIL. CAUSE: NON-UNION SHIFTED CAUSING STRESS TO BE PLACED ON THE DISTAL END OF THE IM NAIL AND CAUSING THE NAIL TO BREAK AT A WEAK POINT (SCREW SLOT). NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10461 STANDARD IM NAIL STANDARD IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization