BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TAP (CANNULATED)

    MDR report key: 4243376 · Received November 11, 2014

    Report

    Report Number
    1723170-2014-01210
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 15, 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
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF SUSPECT TAP AS FOLLOWS: AS REPORTED, A GUIDE WIRE HAS BEEN BROKEN OFF INSIDE THE TAP. ALSO, THE TIP OF THE INSTRUMENT HAS BEEN BLUNTED AND SLIGHTLY FLUTED OUT. OTHERWISE, THE TAP IS IN GOOD CONDITION AND INSERTS AND RELEASES EASILY FROM A NAVLOCK.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RETURN REQUESTED. REPLACEMENT 4.5 TAP SHIPPED TO SITE (B)(4) 2014. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    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 RECEIVED A REPORT FROM A SITE THAT WHEN ATTEMPTING TO CLEAN THEIR 4.5MM CANNULATED TAP, A METAL WIRE BECAME LODGED IN THE CANNULA. AN OBSTRUCTION, AND WIRE, ARE STUCK IN THE TAP. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725150 4.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 130722

    Patients

    Seq Age Sex Outcome Treatment
    1