MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC TERATRACKER, PURPLE; INSTRUMENT, STEREOTAXIC

Model Number	9730492
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 regarding a navigation device being used outside of a procedure.It was reported that a screw for the tracker was worn out.The tracker was not able to be fixed to the instrument.There was no patient present when this issue was observed.
Additional Manufacturer Narrative
Device evaluation: the tracker was returned for hardware analysis.Visual/physical examination and functional testing were performed.The returned tracker was well worn but fully functional.The attachment screw was intact and functional.With markers attached and fully seated, the tracker returned a good geometry error with normal tracking.There was no problem or failure found with the returned tracker.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TERATRACKER, PURPLE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8386772
• Report Number: 1723170-2019-00889
• Device Sequence Number: 277718
• Product Code: HAW
• UDI-Device Identifier: 00721902652295
• UDI-Public: 00721902652295
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 9730492
• Device Catalogue Number: 9730492
• Device Lot Number: 160707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1