BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVE HOOK

    MDR report key: 2500359 · Received March 13, 2012

    Report

    Report Number
    2500359
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    September 29, 2011
    Report Date
    March 6, 2012
    Manufacturer
    LIFE INSTRUMENTS
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    DURING KNEE ARTHROSCOPY, THE TIP OF THE NERVE HOOK INSTRUMENT BROKE OFF WHILE ATTEMPTING TO PULL THE MENISCUS OUT. THE TIP WAS RETRIEVED FROM THE SURGICAL SITE WITHOUT INCIDENT AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NERVE HOOK NERVE HOOK GDG LIFE INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR NO OTHER THERAPIES