MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. PASSIVE BIOPSY NEEDLE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	9733068
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used intra-operatively during a cranial biopsy procedure.It was reported that after registering the patient and switching to navigation mode, where the subsequent trajectory creation for the optical biopsy entry took place, the navigation could not display the biopsy needles (the navigation balls on the stealth station s8 system camera were not visible).The balls on the needle were fixed and did not move.The needles were replaced with two pieces and the same lot number.The site was using digital intercommunication of medicine (dicom) exam, stealth archive exam, and core files.No known impact to patient outcome.There was a 30 minute surgical delay.
Additional Manufacturer Narrative
H3, h6: the biopsy needle kit was returned to the manufacturer for analysis.Both biopsy needles had normal tracking when used with a known good system.One of the two inners sleeves was bent.Codes b01, c13 and d02 are applicable to this analysis.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: PASSIVE BIOPSY NEEDLE
• 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: 23391540
• Report Number: 1723170-2025-03551
• Device Sequence Number: 18653775
• Product Code: HAW
• UDI-Device Identifier: 00643169702943
• UDI-Public: (01)00643169702943(17)250501(10)066512123
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K971247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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 Expiration Date: 05/01/2025
• Device Model Number: 9733068
• Device Catalogue Number: 9733068
• Device Lot Number: 066512123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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