MAUDE Adverse Event Report: MDT Powered Surgical Solutions ENT MR8; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	1847ATTSV
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction

• Brand Name: ENT MR8
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• 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 ; +1(763)526-5677
• MDR Report Key: 50171450
• Report Number: 1625507-2026-06561
• Device Sequence Number: 20893763
• Product Code: ERL
• UDI-Device Identifier: 00763000356989
• UDI-Public: (01)00763000356989(11)211018
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/07/2026

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: 1847ATTSV
• Device Catalogue Number: 1847ATTSV
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown