MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX LEGEND; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	T14MH25
Medical Device Problem Codes	Fracture (1260); Overheating of Device (1437)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that tool received used/ fractured at tip.The likely cause was identified as tool was applicated with too much force/ pressure causing it to fracture off; not sure what caused it to "overheat".This regulatory report is being submitted due to a retrospective review through capa 624392.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 the health care professional complained that the stylus motor was heating up during the surgery and the bur broke subsequently.A second bur (same lot number) was used to replaced the broken bur; the same incident happened.A third bur was used to replace the broken bur and the hcp managed to finish the surgery.Broken pieces of the tool were found in the patient which were later retrieved.On follow-up it was reported that there was no patient or staff impact, and there was a delay of 10 minutes (2 times troubleshooting as 2 burs broke during the surgery) during delay burrs were replaced.It was also reported that there was no prolonged exposure to anesthesia and no intervention was performed.

• Brand Name: MIDAS REX LEGEND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE
• 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: 21863304
• Report Number: 1625507-2025-01460
• Device Sequence Number: 4593682
• Product Code: HBE
• UDI-Device Identifier: 00763000061968
• UDI-Public: 00763000061968
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 04/18/2025

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: T14MH25
• Device Catalogue Number: T14MH25
• Device Lot Number: H5836036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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