MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS MIDAS REX MR8; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-10BA50DX
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-op lumbar fusion, tool broke.It was reported that there was no patient impact.There was delay of less than an hour as a result of this event.
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that the ball tip did indeed break/ cleanly fracture off the dissecting tool stem.There seems to be some foreign matter on tip, as well as discoloration from possible excessive heat.The circular lines/ indentions on stem might come from worn/ bad bearings as well, there discoloration/ corrosion.The most likely cause of failure is excessive force during use leading the device to break.Ifu warns to ¿not use excessive force to pry or push bone with the attachment or dissecting tool.* additional failures not related to reported issue: n/a b3: date of event or estimated date of incident not provided to manufacturer this regulatory report is being submitted due to 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MIDAS REX MR8
• 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: 21734059
• Report Number: 1625507-2025-01152
• Device Sequence Number: 4197145
• Product Code: HBE
• UDI-Device Identifier: 00763000487317
• UDI-Public: 00763000487317
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: MR8-10BA50DX
• Device Catalogue Number: MR8-10BA50DX
• Device Lot Number: 0224289750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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: Male
• Patient Weight: 86 KG