MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	9734734
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system.It was reported the site had a defective tracker.This issue was noted outside of a procedure, and there was no patient involvement.
Additional Manufacturer Narrative
The tracker 9734734 navlock universal green (lot# 171115) was returned and analysis found physical damage.Both side tabs were broken off at the tip.Otherwise, with markers attached and fully seated, the tracker returned a good geometry error.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received stating the defective tracker was not able to verify.

• Brand Name: STEALTHSTATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8247766
• Report Number: 1723170-2019-00248
• Device Sequence Number: 11245091
• Product Code: OLO
• UDI-Device Identifier: 00643169101968
• UDI-Public: 00643169101968
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K124004
• 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,Followup,Followup
• Report Date (Section B): 05/30/2019

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: No Information
• Device Model Number: 9734734
• Device Catalogue Number: 9734734
• Device Lot Number: 171115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/21/2019; 05/29/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/21/2019; 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1