MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX STEALTH-MIDAS MR8; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	EM800N
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 product analysis: evaluation could not confirm the reported malfunction.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: mr8-avs14, serial/lot #: (b)(6), udi#: (b)(4) ; product id: mr8-ava14, serial/lot #: (b)(6) , udi#: (b)(4) ; product id: mr8-avs14, serial/lot #: (b)(6), udi#: (b)(4) ; product id: mr8-ava14, serial/lot #: (b)(6) , udi#: (b)(4).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
It was reported that during l3-l5 posterior decompression and fusion procedure, drill was glowing, could smell smoke and visibly see smoke coming from drill.It was reported that there was no injury to the patient due to the event and the procedure was extended for five minutes.The drill was wrapped in wet laps and removed from the room and the procedure was completed with backup products.Addtional information received from facility stated that the replacement drill also exhibiting overheating issues and required multiple burrs to complete the procedure.

• Brand Name: MIDAS REX STEALTH-MIDAS MR8
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer (Section G): MDT POWERED SURGICAL SOLUTIONS; 4620 n beach st; fort worth TX 76137
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22174198
• Report Number: 1625507-2025-01667
• Device Sequence Number: 13141699
• Product Code: HAW
• UDI-Device Identifier: 00763000430924
• UDI-Public: 00763000430924
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K183644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: EM800N
• Device Catalogue Number: EM800N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown