MAUDE Adverse Event Report: MEDTRONIC INC BIOPSY GUIDE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	960-539
Medical Device Problem Codes	Component Missing (2306); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3) no parts have been returned for 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.
Event or Problem Description
Medtronic received information regarding a navigation system being used for a brain biopsy.It was reported that the biopsy guide failed to lock securely, during instrument installation, even when the locking mechanism was fully engaged, due to the absence of the connection point's positioning pin.The doctor had to use another tool to finish the procedure.There was no reported patient impact and no reported delay.Anesthesia had been administered when the issue occurred.

• Brand Name: BIOPSY GUIDE
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC INC; 826 coal creek cir #100; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC INC; 826 coal creek cir #100; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22073020
• Report Number: 1723170-2025-02055
• Device Sequence Number: 18320659
• Product Code: HAW
• UDI-Device Identifier: 00763000337131
• UDI-Public: 00763000337131
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 960-539
• Device Catalogue Number: 960-539
• Device Lot Number: 0011506764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/17/2022
• 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 Age: 57 YR
• Patient Sex: Male