BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH WIRES

    MDR report key: 3192994 · Received June 27, 2013

    Report

    Report Number
    1020279-2013-00338
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    DZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OVERLOAD FRACTURE MAY HAVE OCCURRED DURING THE REPORTED FALLS. FATIGUE CRACKING IS CAUSED BY THE WIRE BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2013 DUE TO A BROKEN WIRE BETWEEN THE OUTSIDE OF THE LEFT LEG AND THE RING. ACCORDING TO INFORMATION FROM THE HOSPITAL THE (B)(6) PATIENT WAS KNOWN TO FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292555 SMOOTH WIRES WIRE BAY PT CORTICAL 370MM DZK SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R