MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ENT MR8; MOTOR, DRILL, ELECTRIC

Model Number	1847DRLMTR
Medical Device Problem Codes	Overheating of Device (1437); Device Remains Activated (1525); Difficult to Remove (1528); Vibration (1674)
Health Effect - Clinical Codes	Dural Tear (1417); Perforation (2001); Brain Injury (2219)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1 847drlmtr, serial/lot #: (b)(6), udi#: (b)(4); product id: 1847drlmtr, serial/lot #: (b)(6), udi#: (b)(4).H3:no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.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 intraoperative use, all three drills were heating up at the hand piece and one drill jumped forward, causing damage to the dura.The drill jumping forward resulted in a dural injury.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 1 847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: 1847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: 1847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: 1847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: 1847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); product id: 1847attas, serial/lot #: (b)(6), ubd: , udi#: (b)(4); h3:product analysis for 1847drlmtr serial# (b)(6):evaluation confirmed overheating.The device was tested and the maximum temperature was measured to be 135°f.The likely cause of failure could not be determined.It was also noted that the collet depth is out of spec.The stator is loose in the housing.H3: product analysis for 1847drlmtr serial# (b)(6): evaluation confirmed overheating.The device was tested and the maximum temperature was measured to be 137°f.The likely cause of failure could not be determined.It was also noted that the stator is loose in the housing.H3: product analysis for 1847drlmtr serial# (b)(6): evaluation confirmed overheating.The device was tested and the maximum temperature was measured to be 127°f.The likely cause of failure could not be determined.It was also noted that the stator is loose in the housing.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.
Additional Manufacturer Narrative
H3: product analysis of 1847attas with serial#(b)(6):-evaluation confirmed overheating.The device was tested and the maximum temperature was measured to be 120°f.The likely cause of failure could not be determined.It was also noted that the laser markings are fading.Product analysis of 1847attas with serial#(b)(6): no conclusion can be drawn.Evaluation could not be performed because bearings were detached.Product analysis of 1847attas with serial#(b)(6): evaluation confirmed overheating.The device was tested, and the maximum temper ature was measured to be 206°f.The likely cause of failure could not be determined.It was also noted that the drive shaft, input worn.Product analysis of 1847attas with serial#(b)(6):evaluation determined that there was no failure found.Product analysis of 1847attas with serial#(b)(6):evaluation could not confirm the reported malfunction of overheating and vibration.The likely cause was identified as it's not possible to lock a bur in the attachment.It was also noted bearings were detached 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.
Additional Manufacturer Narrative
H3: product analysis of attachment 1847attss with serial number (b)(6): evaluation determined that there was no failure found with the device.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: ENT MR8
• Common Device Name: MOTOR, DRILL, ELECTRIC
• 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: 24017597
• Report Number: 1625507-2026-00012
• Device Sequence Number: 10584130
• Product Code: HBC
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1847DRLMTR
• Device Catalogue Number: 1847DRLMTR
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 05/13/2026; 06/19/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/17/2026; 06/08/2026; 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11"; "SEE H11...."
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown