BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX INC.

    MDR report key: 180183 · Received July 30, 1998

    Report

    Report Number
    180183
    Event Type
    Injury
    Date Received
    July 30, 1998
    Date of Event
    July 21, 1998
    Report Date
    July 29, 1998
    Manufacturer
    ARTHREX INC.
    Product Code
    HRY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ARTHROSCOPIC PROCEDURE A GUIDE WIRE WAS PLACED INTO KNEE & BROKE IN HALF. BOTH PIECES WERE RETRIEVED BY THE SURGEON. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX INC. Implant GUIDE WIRE WITH EYE (ACL RECONSTRUCTION SYSTEM) HRY ARTHREX INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention