MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CRANIAL REFERENCE FRAME SMALL PASSIVE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	961-337
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system being used during a cranial resection procedure.It was reported that during a cranial resection procedure, the passive planar and small passive cranial frame intermittently failed to track when angling the passive planar.The site attempted to resolve the issue by swapping navigation systems, but this did not lead to a resolution.Subsequently, the frame and pointer were swapped, allowing the procedure to continue.The manufacturer representative attempted navigation outside of surgery and encountered the same tracking issue when angling the probe.It was verified that there was no geometry error exceeding the limit for any particular sphere when covering up one sphere at a time on both instruments.No patient complications have been reported as a result of this event and surgical delay was 10-minutes.
Additional Manufacturer Narrative
H3, h6) the instrument has not returned to the manufacturer 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.

• Brand Name: CRANIAL REFERENCE FRAME SMALL PASSIVE
• 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: 22081305
• Report Number: 1723170-2025-02075
• Device Sequence Number: 9501112
• Product Code: HAW
• UDI-Device Identifier: 00721902467783
• UDI-Public: 00721902467783
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2025

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: 08/31/2012
• Device Model Number: 961-337
• Device Catalogue Number: 961-337
• Device Lot Number: 270331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2010
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 83 KG