BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN IM NAIL

    MDR report key: 3261352 · Received July 23, 2013

    Report

    Report Number
    3034525-2013-00038
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 23, 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

    CAUSE: FWB OR OTHER FORCE ON A FEMORAL NON-UNION WITH AN IMPLANTED IM NAIL. FRACTURE REPAIR AND HEALING IS ALWAYS UNIQUE TO THE PT AND THE FRACTURE. GUIDANCE ON BEST PRACTICE FOR SIGN NAILING SURGERY IS INCLUDED IN THE SIGN TECHNIQUE MANUAL; HOWEVER NO ONE CAN PREDICT A NON-UNION OR A FAILURE. THEREFORE NO CORRECTIVE ACTION IS INDICATED OR WOULD HELP PREVENT THIS TYPE OF SITUATION FROM HAPPENING AGAIN. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343543 SIGN IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR