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

Model Number	9734682
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The navlock tracker was returned to the manufacturer for analysis.Analysis found the returned tracker would not accept a known good instrument.Closer examination revealed galling, just inside the tracker at the top end.The tracker did return good geometry error with markers attached and fully seated.The reported event was related to a galling (mechanical) issue.Device manufacturing date is unavailable.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the violet navlock was damaged.There was no patient present when this issue was observed.

• Brand Name: NAVLOCK TRACKER UNIVERSAL VIOLET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7832676
• Report Number: 1723170-2018-04306
• Device Sequence Number: 1966546
• Product Code: OLO
• UDI-Device Identifier: 00763000054298
• UDI-Public: 00763000054298
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2018

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: 9734682
• Device Catalogue Number: 9734682
• Device Lot Number: 180409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/30/2018
• Supplement Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1