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

Model Number	CB11BA40D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both burs broke after a few seconds during the set up.There were no fragments left inside the patient and there was no delay in procedure as a result of the event.It was reported that there was no patient impact.The procedure was completed with the backup product.Upon follow up it was confirmed that there was no additional intervention was performed and the procedure was spine surgery.
Additional Manufacturer Narrative
H3: product analysis: this is well-known failure mode.The most likely cause of failure is variation in the manufacturing process that caused tang weld to fail after some use, leading to fatigue failure at the stem.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.

• Brand Name: MIDAS REX
• 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: 21718034
• Report Number: 1625507-2025-01136
• Device Sequence Number: 4514857
• Product Code: HBE
• UDI-Device Identifier: 00643169766228
• UDI-Public: 00643169766228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072315
• 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
• Report Date (Section B): 03/28/2025

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 Expiration Date: 07/20/2025
• Device Model Number: CB11BA40D
• Device Catalogue Number: CB11BA40D
• Device Lot Number: 0222732145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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