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

Model Number	9736060
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned tracker indicated that it had galling within the handle not allowing instruments to be inserted.Otherwise, with markers attached and fully seated, the tracker returns a good geometry error with normal tracking.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information from a manufacturer representative (rep) regarding a guidance device being used outside of a procedure.It was reported that the black navlock would not allow an instrument to run through it.There was no patient involved.There were no additional complications reported or anticipated as a result of the event.

• 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: 8869627
• Report Number: 1723170-2019-04397
• Device Sequence Number: 10888269
• Product Code: HAW
• UDI-Device Identifier: 00763000123178
• UDI-Public: 00763000123178
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9736060
• Device Catalogue Number: 9736060
• Device Lot Number: 181023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1