MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ORANGE NAVLOCK INSTRUMENT TRACKER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734683
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The instrument tracker was returned to the manufacturer for evaluation.Testing found that side tabs were removed at the tip of the tracker.It was noted that with markers attached and seated, good geometry and divot error readings returned with normal tracking.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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 orange instrument tracker used alongside the navigation system was defective.There was no patient present when this issue was identified.

• Brand Name: ORANGE NAVLOCK INSTRUMENT TRACKER
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 10511307
• Report Number: 1723170-2020-02400
• Device Sequence Number: 16892310
• Product Code: OLO
• UDI-Device Identifier: 00763000076634
• UDI-Public: 00763000076634
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2020

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: 9734683
• Device Catalogue Number: 9734683
• Device Lot Number: 190711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1