MAUDE Adverse Event Report: Medtronic Xomed Inc. Midas Rex MR8; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-SP12MH30T
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the burr was not working and no irrigation was used.The procedure was completed with backup product.There was no known patient impact with this event.
Additional Manufacturer Narrative
H3: evaluation determined that the tool head was visually inspected under the microscope.The tool head was cleaned and visually inspected under the microscope again.Observed damage to the tool flutes is consistent with metal contact damage.The bur wire fracture occurred 2.7 inches proximally from the tool tip, and the fracture surface has characteristics of a rapid, brittle fracture.The likely cause of the failure was due to the user allowing the tool to make contact with the metal surgical instrument while the drill assembly was still powered.This led to the bur wire fracture and subsequent loss in functionality.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: Midas Rex MR8
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• 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 ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; +1(763)526-5677
• MDR Report Key: 50684694
• Report Number: 1045254-2026-01245
• Device Sequence Number: 16058233
• Product Code: HBE
• UDI-Device Identifier: 00763000513948
• UDI-Public: (01)00763000513948(17)300304(10)0233402830(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183515
• 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): 09/09/2026

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: MR8-SP12MH30T
• Device Catalogue Number: MR8-SP12MH30T
• Device Lot Number: 0233402830
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2026
• 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