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

Model Number	9734680
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.The probe was returned to the manufacture for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The returned probe had a bent tip, impact marks at the back end, and severe galling lines on the shaft that will not allow insertion into any mating tracker.Mechanical damage was observed.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 outside of a procedure that there were three thoracic probe tips that were damaged and stuck into two navlock orange trackers.No was patient present at time of discovery.
Additional Manufacturer Narrative
Correction was made to the analysis of the returned probe had a bent tip, impact marks at the back end, and severe galling lines on the shaft that will not allow insertion into any mating tracker.If information is provided in the future, a supplemental report will be issued.

• Brand Name: THORACIC PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9315922
• Report Number: 1723170-2019-05590
• Device Sequence Number: 13550782
• Product Code: OLO
• UDI-Device Identifier: 00763000054205
• UDI-Public: 00763000054205
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K124004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 190417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1