MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NAVLOCK TRACKER UNIVERSAL VIOLET; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734682

Device Problem Imprecision (1307)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 12/15/2016

Event Type  Injury  

Manufacturer Narrative

Return requested for suspect navlock universal violet tracker.No parts have been received by manufacturer for analysis.On 12/16/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 01/04/2016 a medtronic representative, following-up at the site, reported that the surgeon did need to re-position the screw.The inaccuracy was alleged to be 4-5 millimeters off at the tip of the screw, it was enough where every one of the screws appeared bad going in (on the navigation system) and the surgeon compensated to place them correctly.The patient weighed approximately (b)(6).Noted was that a subsequent procedure was performed using the green navlock and everything was spot on.Part not received by manufacturer.

Event Description

A medtronic representative reported that while in an open transforaminal lumbar interbody fusion (tlif) procedure, the site reported their violet navlock was having difficulty tracking.The site reported the instrument was tracking inaccurately, however, did not provide additional information.No further details regarding this issue, or specifically when it occurred, were provided.In trouble-shooting, the violet navlock was on the solera 5.5/6.0 mas driver, and it was ensured that the balls were all on fully.The instrument initially verified, however, during screw placement it gave an inaccurate trajectory and multiple screws were attempted.Attempts made to re-verify the navigation system, continually gave error messages that we were too far from the divot.This continued to occur with all divots and with both mas drivers.Green tracker on the mas driver verified immediately and gave an accurate trajectory.The overall delay created a need for a second spin to ensure that the first two screws were accurate, opening another pan to get a replacement driver, placing a screw more lateral than desired.The surgeon is fine using the green tracker as that worked, however, deemed this still leaves the violet tracker as a liability.The surgeon re-positioned the screw after his confirmation spin and confirmed it was only the one screw.The surgeon completed the procedure with the use of the navigation system.Delay in therapy was less than one hour.

Manufacturer Narrative

Additional information: although a specific cause of the reported incident was unconfirmed as the part was not returned to the manufacturer, an investigation into returned violet navlock trackers appear to be caused by handling damage due to repeat usage.No adverse complaint trend for any other failure mode has been identified.The medtronic representative reported that the instrument initially verified but after the inaccuracy was detected the instrument was unable to be re-verified.This indicates the device was damaged after the initial verification.The instructions for use which accompanies the navigation system states: "warning: prior to use, examine all components for damage and deterioration.Do not use any compromised component.Abandon use of any component damaged during the procedure.".

Manufacturer Narrative

The suspect violet navlock tracker was returned to the manufacturer for analysis.The navlock was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• Brand Name: NAVLOCK TRACKER UNIVERSAL VIOLET
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902082
• MDR Report Key: 6248320
• MDR Text Key: 64715451
• Report Number: 1723170-2017-00141
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734682
• Device Lot Number: 160418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 104