MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) GREEN TERATRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number	9730490
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable.No parts have been received by the manufacturer for evaluation.A medtronic representative reported that the issue was caused by the screw of the tera tracker green was worn away.The medtronic representative replaced the screw which resolved the issue.
Event or Problem Description
A medtronic representative reported that the tactile awl instrument had a screw hole that wasn't allowing the tera tracker to seat securely.The site used a different instrument to proceed with the case.There was no patient impact or delay in surgery reported.Surgery proceeded as planned.
Additional Manufacturer Narrative
Lot number provided.
Additional Manufacturer Narrative
The device was returned to the manufacturer for analysis.The returned tracker was worn but still functional.The attachment screw was intact and without damage.The tester was able to attach the tracker without issue.With markers attached and fully seated, the tracker returned good geometry error.The device was found to be fully functional with no problem found.Due to these findings and the tactile awl not being returned, the reported event could not be duplicated by medtronic personnel.

• Brand Name: GREEN TERATRACKER
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 6335534
• Report Number: 1723170-2017-00783
• Device Sequence Number: 16349356
• Product Code: HAW
• UDI-Device Identifier: 00721902652271
• UDI-Public: 00721902652271
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2017

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 9730490
• Device Lot Number: 120319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/16/2017; 05/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1