BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATED CD HORIZON® SOLERA¿ REDUCTION 4.75 SCREWDRIVER

    MDR report key: 4133149 · Received October 1, 2014

    Report

    Report Number
    1723170-2014-01037
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PART WAS INSPECTED UNDER A MICROSCOPE AND TIP OF THE DRIVER WAS NOT DAMAGED. A SCREW WAS ATTACHED TO THE TIP AND THERE WAS NO PLAY OR MOVEMENT. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A 4.75 SOLERA DRIVER THAT WAS REPORTED BY THE SITE TO BE STRIPPED. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611720 NAVIGATED CD HORIZON® SOLERA¿ REDUCTION 4.75 SCREWDRIVER ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 110412

    Patients

    Seq Age Sex Outcome Treatment
    1