BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS, FREER ELEVATOR

    MDR report key: 105099 · Received July 1, 1997

    Report

    Report Number
    105099
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    April 24, 1997
    Report Date
    May 5, 1997
    Manufacturer
    SMITH & NEPHEW INC.
    Product Code
    GEG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ENDOSCOPIC CARPAL TUNNEL RELEASE, FREER ELEVATOR INSERTED INTO INCISION. DURING USE, TIP BROKE OFF. SURGEON HAD TO DO OPEN PROCEDURE RATHER THAN PROCEEDING WITH ENDOSCOPIC APPROACH IN ORDER TO RETRIEVE PIECE WHICH HAD BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS, FREER ELEVATOR ELEVATOR, ORTHOPEDIC GEG SMITH & NEPHEW INC. * 283.04

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention