MAUDE Adverse Event Report: MDT Powered Surgical Solutions MIDAS REX LEGEND; MOTOR, DRILL, PNEUMATIC

Model Number	AS09S
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2026
Type of Reportable Event	Malfunction

• Brand Name: MIDAS REX LEGEND
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• 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: 50928966
• Report Number: 1625507-2026-08272
• Device Sequence Number: 21265913
• Product Code: HBB
• UDI-Device Identifier: 00763000084813
• UDI-Public: (01)00763000084813(11)181002
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020069
• 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): 09/29/2026

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: AS09S
• Device Catalogue Number: AS09S
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2018
• 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