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

Catalog Number	9734403
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/07/2018
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.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Device not returned.
Event or Problem Description
Medtronic received information regarding a navigation system event having occurred outside of procedure.It was reported that the site had two bent thoracic probes that needed to be replaced.It was unknown whether or not the probes would have verified as the site disposed of the probes or lost them prior to analysis.No patient present.

• 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: 7891085
• Report Number: 1723170-2018-04856
• Device Sequence Number: 13908075
• Product Code: OLO
• UDI-Device Identifier: 00763000053802
• UDI-Public: 00763000053802
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: Health Professional
• Device Catalogue Number: 9734403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1