MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - STYLUS TRANSNASAL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	TN30MCD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pituitary procedure, the device was not working.The procedure was completed with backup product.There was no patient impact in this event.Analysis found that the inner shaft were broken.
Additional Manufacturer Narrative
H3: visually, there was no damage noted (with unaided eye) in the construction of the device.There were traces of a brown residue found at the distal end of the hub under the silicone boot.Functionally, the device was loaded into a handpiece and ran up to 60, 000rpm in forward mode.However, during the functional testing, the diamond ball was not moving/spinning.For further analysis, the diamond ball was spun and lightly pulled by hand and there was no resistance noted while pulling the diamond ball.The inner shaft/tool came easily out of the curved tube, it was broken.The broken inner shaft/tool measured 5.69 inches from the diamond ball to the broken point.There were traces of discoloration and striations noted near the diamond ball.There were also indentions noted near the broken point of the inner shaft/tool.The device failed due to defective condition upon return and the inability to spin.A review of the global complaint data showed one other complaints about this lot number.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).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: XPS® BUR - STYLUS TRANSNASAL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 21395828
• Report Number: 1045254-2025-00501
• Device Sequence Number: 15764289
• Product Code: ERL
• UDI-Device Identifier: 00613994776204
• UDI-Public: 00613994776204
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081277
• 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): 02/17/2025

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: 06/03/2025
• Device Model Number: TN30MCD
• Device Catalogue Number: TN30MCD
• Device Lot Number: 0227929195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• 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