MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC OSTIUM SEEKER, AXIEM; INSTRUMENT, STEREOTAXIC

Model Number	9733448
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number not available on the date of filing.Manufacture date not available on the date of filing.No parts have been received by the manufacturer for evaluation.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 outside of a procedure that the site had a damaged ostium seeker instrument.There was no patient present.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow-up with the manufacturer representative (rep) determined that the instrument was discarded.The site told the rep that upon opening the tray the instrument was visibly bent and the surgeon confirmed that the instrument would not verify.

• Brand Name: OSTIUM SEEKER, AXIEM
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; navigation customer quality; 826 coal creek circle; louisville,co 80027
• MDR Report Key: 8407385
• Report Number: 1723170-2019-01032
• Device Sequence Number: 389804
• Product Code: HAW
• UDI-Device Identifier: 00763000053406
• UDI-Public: 00763000053406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: Health Professional
• Device Model Number: 9733448
• Device Catalogue Number: 9733448
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1