BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERTAN NAILS

    MDR report key: 2901425 · Received January 8, 2013

    Report

    Report Number
    1020279-2013-00018
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT WAS NOT AVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. A SAMPLE NAIL FROM THE SAME BATCH WAS AVAILABLE AND RETURNED. AN EVALUATION OF THE RETURNED SAMPLE REVEALED THE NAIL TO MEET SPECIFICATION WITH NO MATERIAL OR MANUFACTURING DEFECTS. A REVIEW OF COMPLAINT HISTORY REVEALED NO OTHER COMPLAINTS FOR THIS BATCH. WITH THE INFORMATION CURRENTLY AVAILABLE WE ARE CONCLUDING THAT THE NAILS IN THE SPECIFIIED BATCH ARE THE CORRECT ANGLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NAIL PACKAGED, LABELED AND MARKED AS 130 DEGREE ANGLE NAIL WAS ACTUALLY A 125 DEGREE ANGLE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9204 INTERTAN NAILS INTERTAN 10MM X 18CM 130D JDS SMITH & NEPHEW, INC. 12HM13482

    Patients

    Seq Age Sex Outcome Treatment
    1