BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL NAVLOCK INSTRUMENT SET

    MDR report key: 5745441 · Received June 23, 2016

    Report

    Report Number
    1723170-2016-01214
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 31, 2016
    Report Date
    September 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    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

    THE POTENTIAL RISK ASSOCIATED WITH THE REPORTED INCIDENT WAS WITH THE USER, AND NOT THE PATIENT. THEREFORE, ESTIMATED DEMOGRAPHICS OF THE USER ARE PROVIDED. TWENTY ONE NAVIGATED SPINE INSTRUMENTS WERE REPLACED WITH THE FOLLOWING LOT NUMBERS AND MANUFACTURE DATES: TRACKER 9734734 NAVLOCK UNIVERSAL GREEN (X2): 151023, 23OCT2015; TRACKER 9734683 NAVLOCK UNIVERSAL ORANGE (X2): 150928, 28SEP2015; TRACKER 9734590 NAVLOCK UNIVERSAL GREY (X1): 150929, 29SEP2015; TAP 9734303 7.5 (X2): 150616, 16JUN2015; TAP 9734301 6.0 (X2): 150217, 17FEB2015; TAP 9734299 5.0 (X2): 150218, 18FEB2015; TAP 9734300 5.5 (X2): 150601, 01JUN2015; TAP 9734297 4.0 (X2): 150707, 07JUL2015; TAP 9734298 4.5 (X2): 150513, 13MAY2015; TAP 9734296 3.75 (X2): 150820, 20AUG2015; TAP 9734302 6.5 (X2): 150617, 17JUN2015. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO INSPECT ALL THE NAVIGATED SPINE INSTRUMENTS. THE REP IDENTIFIED SOME FIT ISSUES AND RETURNED SEVERAL INSTRUMENTS TO THE MANUFACTURER FOR EVALUATION. THE RETURNED 5 TRACKERS WERE FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. KNOWN GOOD INSTRUMENTS INSERTED, ROTATED AND RELEASED WITHOUT ISSUE. WITH MARKERS ATTACHED AND FULLY SEATED, THE TRACKERS RETURNED GOOD GEOMETRY AND DIVOT READINGS. THEY WERE ALL FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE RETURNED 7.5, 6.0, 4.0, AND 4.5 TAPS WERE FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE TAPS INSERTED, ROTATED, AND RELEASED FROM A KNOWN GOOD NAVLOCK TRACKER AS WELL AS THE RETURNED TRACKERS WITHOUT ISSUE. THEY WERE ALL FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE 5.0, 5.5, AND 3.75 TAPS HAVE NOT BEEN RETURNED FOR EVALUATION. ONE OF THE RETURNED 6.5 TAPS WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE TAP INSERTED, ROTATED, AND RELEASED FROM A KNOWN GOOD NAVLOCK TRACKER AS WELL AS THE RETURNED TRACKERS WITHOUT ISSUE. IT WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL. THE OTHER 6.5 TAP HAD SIGNS OF GALLING ON THE BACK END OF THE SHAFT CAUSING FIT ISSUES. ALL THE INSTRUMENTS WERE REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE 5.0, 5.5, AND 3.75 TAPS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED TAPS WERE FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE TAPS INSERTED, ROTATED, AND RELEASED FROM A KNOWN GOOD TRACKER AS WELL AS THE RETURNED TRACKERS WITHOUT ISSUE. THE DEVICES WERE FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED ON THESE INSTRUMENTS BY MEDTRONIC PERSONNEL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT INSTRUMENTS IN THE NAVIGATED SPINE SET WERE DIFFICULT TO PLACE AND REMOVE FROM SEVERAL TRACKERS DURING A SPINE PROCEDURE. THE SURGEON WAS USING THE INSTRUMENTS UNDER POWER. THEY CONTINUED THE CASE WHILE THEY FOUND COMBINATIONS THAT WOULD WORK FOR THE PROCEDURE. THE ISSUE DELAYED THE CASE BY 5 MIN WITH NO PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400833 UNIVERSAL NAVLOCK INSTRUMENT SET ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR