MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION NAVIGATED CERVICAL PROBE; INSTRUMENT, STEREOTAXIC

Model Number	9733457
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the cervical probe was deformed.This issue was noted outside of a procedure, and there was no patient involvement.Additional information was received stating the deformed probe was able to be verified.
Additional Manufacturer Narrative
The probe was returned to the manufacturer for analysis.Functional testing determined that the returned probe has a visibly bent tip.With markers attached and fully seated, the probe returned a good geometry error but a very high divot error due to the bent tip.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION NAVIGATED CERVICAL PROBE
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 9721041
• Report Number: 1723170-2020-00550
• Device Sequence Number: 16974262
• Product Code: HAW
• UDI-Device Identifier: 00613994335968
• UDI-Public: 00613994335968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• 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
• Report Date (Section B): 04/17/2020

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: 9733457
• Device Catalogue Number: 9733457
• Device Lot Number: 170222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1