BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 2926271 · Received January 18, 2013

    Report

    Report Number
    3034525-2013-00006
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 18, 2012
    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

    REVIEW OF THE SURGEON'S REPORT AND DATABASE INDICATES A BROKEN SIGN IM NAIL. REVIEW OF THE PT X-RAYS CONFIRMS THE BROKEN NAIL AND SHOWS A NON-UNION, WHICH APPEARS TO HAVE SHIFTED, PLACING A HIGH LEVEL OF STRESS ON THE DISTAL END OF THE NAIL CAUSING A LEVER AFFECT AND THE BREAK. SURGEON STATES THAT THE PT HAS HAD MULTIPLE SURGERIES AND THE NON-UNION MAY BE AS OLD AS 4 - 5 YEARS AND MAY HAVE BEEN COMPLICATED BY FWB OF THE PT. CAUSE: LONG STANDING NON-UNION WITH FWB CAUSED THE NON-UNION TO SHIFT RESULTING IN INCREASED STRESS ON THE DISTAL END OF THE IM NAIL RESULTING IN BREAKAGE OF THE NAIL AT ONE OF THE DISTAL SCREW SLOTS. NO INDICATION ON PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28198 STANDARD IM NAIL STANDARD IM NAIL HSB SIGN FRACTURE CARE INTERNATIONAL STANDARD IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization