MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAV THORACIC PROBE TIP; 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	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation system used outside of a procedure.It was reported that the thoracic probe was deformed.There was no patient involved in this event.
Additional Manufacturer Narrative
The probe was returned for analysis.The returned probe had several impact marks at the back end causing the reported fit issues.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAV THORACIC PROBE TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9733545
• Report Number: 1723170-2020-00577
• Device Sequence Number: 11580721
• Product Code: OLO
• UDI-Device Identifier: 00613994870063
• UDI-Public: 00613994870063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: No Information
• Device Model Number: 9734680
• Device Catalogue Number: 9734680
• Device Lot Number: 170223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1