BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STILLE GOUGE

    MDR report key: 2145017 · Received June 22, 2011

    Report

    Report Number
    2145017
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 22, 2011
    Manufacturer
    STILLE SURGICAL, INC.
    Product Code
    GDH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY OF COMPLETE REVERSE TOTAL SHOULDER IMPLANT, THE WOODEN HANDLE OF THE GOUGE BROKE. ALL PIECES WERE RETRIEVED AND NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STILLE GOUGE ORTHOPEDIC GOUGE GDH STILLE SURGICAL, INC. D6020-16 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR