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

Catalog Number	9734734
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.Device lot number, or serial number, unavailable.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.During the onsite inspection, the medtronic representative reported that several instruments were assessed to determine if they were exhibiting any geometry errors.It was found that the green navlock tracker had a visibly bent post.No further damaged instruments were observed.The damaged tracker was not sent back to the manufacturer for further analysis.Part not returned.
Event or Problem Description
A medtronic representative reported that during a case the site tapped a hole using a medtronic tap and when the tracked driver was brought to the hole, the system showed that the driver was not following the same trajectory as the tap.The medtronic representative found that when the tracker was moved on the driver (tilted it at different angles to the camera) the model of the driver shown on the system would shift up and down along the trajectory by a few mm as the tracker was rotated.It was also found that when the camera was moved the tracker would remain in a fixed position, the model of the driver would move up and down the trajectory by a few mm as the camera was moved around.Additionally, tracking difficulty was observed with some of other instruments.There was no patient impact or delay in surgery reported.Surgery proceeded as planned.
Additional Manufacturer Narrative
(b)(6).The reported issue occurred in a spinal fusion.It was reported that an imprecision of 3-5mm was observed.The imprecision was observed during navigation.There was a reported delay to the procedure of less than 1 hour due to this issue.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.The suspect tracker was returned to the manufacturer for evaluation.Testing found that the tracker returned a high divot error when tested.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: NAVLOCK UNIVERSAL GREEN TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6431887
• Report Number: 1723170-2017-01327
• Device Sequence Number: 18911363
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2017

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 Catalogue Number: 9734734
• Device Lot Number: 120525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/22/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/20/2017; 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR