BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1951412 · Received December 30, 2010

    Report

    Report Number
    1951412
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 30, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GZX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALL TIP MICRO NERVE HOOK'S TIP BROKE OFF IN PATIENT WHILE BEING USED BY DOCTOR DURING PROCEDURE. TIP WAS RETRIEVED BY DOCTOR. PER DOCTOR, ALL PIECES OF INSTRUMENT WERE REMOVED FROM THE PATIENT AND PATIENT DID NOT SUSTAIN ANY INJURY FROM THE INSTRUMENT BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INSTRUMENT, MICROSURGICAL GZX CODMAN & SHURTLEFF, INC. BALL TIP MICRO NERVE HOOK TIP *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR NO OTHER THERAPIES