MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVLOCK 9736060 BLACK; INSTRUMENT, STEREOTAXIC

Model Number	9736060
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the instrument tracker was damaged while navigating drill bits.There was no patient present when this issue was identified.No additional information was provided.
Additional Manufacturer Narrative
Analysis of the tracker found no failure.The tracker was able to receive known good instruments without issue.With markers attached and fully seated, both returned good geometry error with normal tracking.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVLOCK 9736060 BLACK
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8418284
• Report Number: 1723170-2019-01101
• Device Sequence Number: 13831986
• Product Code: HAW
• UDI-Device Identifier: 00763000123178
• UDI-Public: 00763000123178
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K182104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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: 9736060
• Device Catalogue Number: 9736060
• Device Lot Number: 180921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1