BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 1803119 · Received August 17, 2010

    Report

    Report Number
    1020279-2010-00228
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS CONCLUDED THAT THE TAN NAIL FRACTURED BY METAL FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE REMAINING CROSS-SECTIONAL AREA OF THE NAIL COULD NOT BEAR THE IMPOSED PATIENT LOADING, LEADING TO OVERLOAD FRACTURE. FATIGUE CRACKING IS CAUSED BY THE NAIL BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, POOR BONE QUALITY, AND CHRONIC NON-UNION OR MAL-UNION OF THE BONE FRACTURE. NO MATERIALS OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NAIL FRACTURED REQUIRING A REVISION SURGERY TO CORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT AN ERROR CODE 5 ON DISPLAY AFTER A FEW MINUTES. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN NAIL JDS SMITH & NEPHEW, INC. 04KM18088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R