MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) THORACIC PROBE TIP; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	9734403
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.Device lot number and serial number, unavailable at the time of filing.No parts have been returned to the manufacturer for analysis.Device manufacture date is not available at time of filing.
Event or Problem Description
Medtronic received information regarding a navigation device being used outside a procedure.It was reported that the thoracic probe was bent.There was no patient present when this issue was identified.

• Brand Name: THORACIC PROBE TIP
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7588889
• Report Number: 1723170-2018-02683
• Device Sequence Number: 1555792
• Product Code: OLO
• UDI-Device Identifier: 00763000053796
• UDI-Public: 00763000053796
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: Physician
• Device Catalogue Number: 9734403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1