MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK UNIVERSAL GREEN TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734734
Medical Device Problem Codes	Human-Device Interface Problem (2949); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A medtronic representative performed a system checkout for the navigation system, and the checkout stated that the green navlock was not always recognized due to a geometry error going up to 0.6mm, mostly if the navlock is not looking straight to the camera.It was noted that the green navlock needed to be replaced.However, no parts have been returned to medtronic for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that during surgery, the green navlock tracker was not always recognized by the camera, mostly when the navlock was not looking straight to the camera.The green navlock was being used with a screw driver.The surgeon noted that it happened often with this green navlock.There were no problems with the orange, grey, and purple navlock trackers.There was no delay due to this issue, and there was no impact on patient outcome.It was noted that the spheres were controlled and had been cleaned.Troubleshooting found that the navlock geometry error was around 0.48 when navigating and up to 0.6 when not navigating.It was noted that one pin seemed to be slightly loose and could not be turned by hand.
Additional Manufacturer Narrative
Device evaluation: the green navlock tracker was returned to medtronic for evaluation.The returned tracker was found to be in good condition with no apparent physical damage.With markers attached and fully seated, the tracker returned a good geometry error with normal tracking.There was no problem found with the tracker.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVLOCK UNIVERSAL GREEN TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8528420
• Report Number: 1723170-2019-01839
• Device Sequence Number: 1885092
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9734734
• Device Catalogue Number: 9734734
• Device Lot Number: 151120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 70