MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. VISUALASE; STYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	9735571
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the was returned to the manufacturer for analysis.Analysis found that the returned anchor was used and looked worn.The plastic shell was cracked near the insert.The insert had been partially pulled out.Analysis found that the reported event was related to a mechanical issue.H6: fdm b01, fdr c07, and fdc d02 are applicable to the hardware 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 thermal therapy system being used during a soft tissue ablation (neuro) procedure.It was reported that the health care professional (hcp) struggled to remove the bone anchor.The bone anchor snapped.The hcp had to make a small incision to use an instrument in order for the bone anchor to be removed.The site stated that after the procedure, the titanium bone anchor was intended to be unscrewed and removed easily but the white plastic part was snapped during removal.The hcp had to make a small incision and used additional instrument to remove the titanium bone anchor.The device came out intact as inspected by the hcp.There was no reported delay to the procedure due to this issue.There was no reported impact to the patient.

• Brand Name: VISUALASE
• Common Device Name: STYLET, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette,co
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25116856
• Report Number: 1723170-2026-00718
• Device Sequence Number: 10279864
• Product Code: GAH
• UDI-Device Identifier: 00763000416461
• UDI-Public: (01)00763000416461(17)270528(10)2025050056(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (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): 05/07/2026

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: 9735571
• Device Catalogue Number: 9735571
• Device Lot Number: 2025050056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• 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: Male