BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVLOCK TRACKER UNIVERSAL VIOLET

    MDR report key: 3882367 · Received June 18, 2014

    Report

    Report Number
    1723170-2014-00650
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 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
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT INFORMATION FOR THIS CASE IS THAT OF THE PATIENT IN THE PROCEDURE, THE EVENT EFFECTED NOT THE PATIENT, BUT THE SURGEON. THE SURGEON'S DEMOGRAPHIC INFORMATION IS AS FOLLOWS: IDENTIFIER: (B)(6). AGE: (B)(6). GENDER: MALE. WEIGHT: (B)(6). A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THAT THE POWEREASE ADAPTER AND SOLERA DRIVER WERE NOT DAMAGED. A REPLACEMENT NAVLOCK UNIV VIOLET TRACKER WAS SHIPPED TO THE SITE ON (B)(4) 2014 FOR ISSUE RESOLUTION AS IT WAS FOUND TO BE JAMMED TOGETHER WITH A TAP AFTER THE PROCEDURE WHILE IN STERILE PROCESSING AT THE SITE. ANALYSIS OF THE SUSPECT NAVLOCK TRACKER FOUND THAT ABRASIONS INSIDE THE TRACKER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 THAT, WHILE IN A L4-5 SPINE FUSION PROCEDURE, THE SURGEON WAS USING A POWEREASE DRILL WITH A NAVLOCK SOLERA DRIVER AND A NAVLOCK ADAPTER. IT WAS REPORTED THAT THE SITE SCRUB TECHNICIAN WAS HAVING DIFFICULTY GETTING THE SOLERA DRIVER TO SEAT FULLY INTO THE ASSEMBLY. THE POWEREASE ASSEMBLY WAS HANDED TO THE SURGEON, WHO HAD STARTED TO DRILL WHEN THE NAVLOCK TRACKER SPUN AROUND AND HIT THE SURGEON'S HAND. THE MEDTRONIC REPRESENTATIVE NOTED THAT THE SURGEON STEPPED AWAY FROM THE TABLE AND HELD HIS HAND FOR A FEW MOMENTS BEFORE RETURNING TO CONTINUE THE PROCEDURE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356861 NAVLOCK TRACKER UNIVERSAL VIOLET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 120914

    Patients

    Seq Age Sex Outcome Treatment
    1