BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TAP (CANNULATED)

    MDR report key: 3870226 · Received June 12, 2014

    Report

    Report Number
    1723170-2014-00641
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    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. REPLACEMENT TAP 5.5 SHIPPED TO SITE (B)(4) 2014. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THAT, AS REPORTED, THE TIP OF THE INSTRUMENT HAS BEEN BROKEN OFF AND IS BLOCKED WITH BONY MATERIAL. MECHANICAL FAILURE, PIECES BROKEN, DIRECTLY CAUSED EVENT.

    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 BONE STUCK INSIDE A SOLERA 5.5 TAP. DRILL BIT WAS BROKEN OFF IN THE TAP WHILE ATTEMPTING TO REMOVE THE MATERIAL. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347468 5.5MM TAP (CANNULATED) ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 131209

    Patients

    Seq Age Sex Outcome Treatment
    1