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

Model Number	F2/8TA23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn.No evaluation was performed, as the device was returned and waiting for analysis to 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 a craniotomy to treat cerebral hemorrhage, the drill blade broke during the operation, resulting in a 10-minute procedure delay.It was reported that the procedure was completed using a replacement product.At the time of report, there was no known impact to a patient.Additional details regarding intervention and patient impact is being followed up from the facility.Additional information was received stating that there was no patient or staff impact.
Additional Manufacturer Narrative
H3: product analysis: evaluation of the device determined that tool was broken about 3/4 down the fluted portion.The likely cause of failure might be fracture face and location indicate that the tool was used as a prying device while inside a footed attachment.It was also noted that there was surface discoloration and fracture face in both tools is rough and parallel to the stem.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: 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: 23942254
• Report Number: 1625507-2026-00003
• Device Sequence Number: 7874904
• Product Code: HBB
• UDI-Device Identifier: 00763000061890
• UDI-Public: (01)00763000061890(17)300501(10)H6049566(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: F2/8TA23
• Device Catalogue Number: F2/8TA23
• Device Lot Number: H6049566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Weight: 55 KG