MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC INST KIT PROBE THORACIC ASSY; 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	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Device manufacturing date is unavailable.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 that the tip of the thoracic probe was bent.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received additional information that the instrument could not be verified and used because of the bent tip.It was reported that the cause was not known.
Additional Manufacturer Narrative
Additional information:the probe was returned to the manufacturer for analysis.Analysis found that the tip of the returned probe was twisted.There were also impact marks at the back end causing fit issues with the mating tracker.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INST KIT PROBE THORACIC ASSY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8861380
• Report Number: 1723170-2019-04371
• Device Sequence Number: 502870
• Product Code: OLO
• UDI-Device Identifier: 00763000207625
• UDI-Public: 00763000207625
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/16/2019

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: 180629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 09/27/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/04/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1