BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0 INTERNAL CAPTURE

    MDR report key: 2339916 · Received November 17, 2011

    Report

    Report Number
    1020279-2011-00481
    Event Type
    Injury
    Date Received
    November 17, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE RELATED FEATURES HAVE BEEN CHECKED TO CONFIRM THAT THE PART MEETS THE DRAWING REQUIREMENTS, WITH THE EXCEPTION OF SLIGHT DEFORMATION OF THE THREADS AT THE DISTAL END WITH THE ANODIZE COATING REMOVED. THIS DAMAGE POSSIBLY OCCURRED DURING THE ATTEMPTS TO INSERT THE SCREW INTO THE PROXIMAL HOLE OF THE NAIL.

    Description of Event or Problem · 1

    THE SCREW COULD NOT BE INSERTED IN A PROXIMAL HOL OF TRIGEN TAN NAIL, SURGERY TIME WAS EXTENDED 30 MINUTES TO ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0 INTERNAL CAPTURE INT HEX CAP SCR 5.0MM X 65MM HWC SMITH & NEPHEW, INC. 71642265 09LM06311

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R