MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC EM ENT STRAIGHT SUCTION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733449
Medical Device Problem Codes	Mechanical Problem (1384); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation device outside of procedure.It was reported it was unclear whether there was a straight suction deformation, or whether verification could be done or not.There was no patient present.
Additional Manufacturer Narrative
H3/h6: the straight suction was returned and analyzed.It was found that the suction was able to verify when attached to a known good tracker but with some difficulty.The divot error was 1.7 mm to 1.9 mm.Codes b01, c13, and d02 are applicable.Fdd codes a05 and a0709 were used.A05 reflects the potential deformation while a0709 reflects the verification issue.This regulatory report is being submitted due to retrospective review through capa: 626390.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: EM ENT STRAIGHT SUCTION
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21283026
• Report Number: 1723170-2025-00402
• Device Sequence Number: 15835129
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2025

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: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 16030741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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