MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. 70 DEG CURVED SUCTION, AXIEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733450
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G2: foreign country - japan h3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a navigation system being used during a functional endoscopic sinus surgery (fess) procedure.It was reported that the accuracy of the 70-degree suction alone was poor.There was an alleged inaccuracy of 5mm.The site used a different instrument to continue navigation.There was no reported delay, and no patient impact.
Event or Problem Description
Additional information was received.It was reported that the suspected and most likely cause of the reported issue was believed to be deterioration over time.
Additional Manufacturer Narrative
H2) additional information added to b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3, h6: the 9733450, lot 240202 curved suction was returned for evaluation.Analysis found a tracking/verification issue.The reported problem was confirmed.There was a failed registration with an error of 2.5mm.The returned curved suction was found to be in good condition with no noticeable bending or physical damage.Codes b01, c13, and d02 are applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 70 DEG CURVED SUCTION, AXIEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22556008
• Report Number: 1723170-2025-02743
• Device Sequence Number: 9529074
• Product Code: HAW
• UDI-Device Identifier: 00763000053390
• UDI-Public: (01)00763000053390(11)240202(10)240202
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 9733450
• Device Catalogue Number: 9733450
• Device Lot Number: 240202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 10/16/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown