BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD IM NAIL

    MDR report key: 3946373 · Received July 10, 2014

    Report

    Report Number
    3034525-2014-00031
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SIGN FRACTURE CARE INT
    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: AS STATED BY SURGEON; THE OTHER SURGEON DID NOT PLACE THE NAIL IN A GOOD POSITION. FRACTURE REPAIR AND HEALING IS ALWAYS UNIQUE TO THE PATIENT 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. THE OPINION OF THE SURGEON ON THE OTHER SURGEONS PLACEMENT OF THE NAIL DOES NOT CONSTITUTE CONFIRMED USER MISUSE. 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
    403875 STANDARD IM NAIL INTRAMEDULLARY ROD HSB SIGN FRACTURE CARE INT STANDARD IM NAIL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization