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

Model Number	960-539
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a navigation system outside of procedure.It was reported the cervical probe accuracy could not be achieved.The biopsy guide would move, even when it was locked.There was a foreign object in the hollow of the solera.There was no patient involvement.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 960-539, serial/lot #: (b)(6)) the instrument (product id: 960-539) was returned to the manufacturer for evaluation.After visual/physical examination, the reported issue was confirmed.The results concluded that the pivot pin at the top join had been broken off.As a result, the guide has no anchor point and moves unrestrained.Codes: b01, c07, d02 g2) foreign country: japan 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: BIOPSY GUIDE
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19222365
• Report Number: 1723170-2024-01181
• Device Sequence Number: 12498119
• Product Code: HAW
• UDI-Device Identifier: 00681490991520
• UDI-Public: 00681490991520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954276
• Number of Events Summarized: 1
• Summary Report (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): 05/01/2024

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: 030210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2010
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown