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

Catalog Number	9734403
Medical Device Problem Codes	Bent (1059); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations.Device lot number, or serial number, unavailable at the time of filing.Device manufacture date is not available at time of filing.No parts have been returned to the manufacturer for analysis.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.
Additional Manufacturer Narrative
Additional information: device lot number and manufacture date provided.
Additional Manufacturer Narrative
The lumber probe was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue was confirmed.The tip of the returned probe was bent and there were impact marks at the back causing fit issues with the mating tracker.Physical damage was found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a navigation device being used for a sacroiliac and thoracolumbar procedure.It was reported that the lumbar probe was deformed.There was no delay in surgery and no impact on patient outcome.

• 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: 7658961
• Report Number: 1723170-2018-03108
• Device Sequence Number: 10809112
• Product Code: OLO
• UDI-Device Identifier: 00763000053796
• UDI-Public: 00763000053796
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2018

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
• Device Lot Number: 140214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/03/2018; 07/03/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/19/2018; 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1