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

Model Number	ASMC
Medical Device Problem Codes	Overheating of Device (1437); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: an overheating test could not be conducted due to another device malfunction.The likely cause was identified as bearings are worn out and some are stuck/ lodged in attachment.The inner tube of attachment seems to be unthreading as well due to inadequate preventative maintenance.It was also noted that, since the tool was taken apart due to overheating, the failed worn bearings most likely led to the tube unthreading the opposite way, causing rubbing in the tube when its in use and spins, leading to the over heating and ultimate failure of the attachment, especially if someone was trying to put it back together.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 portion of the attachment closest to the tip became loose and slid down cutting tool during use.It was also reported that cutting tool and attachment became hot and attachment had been dismantled and in multiple pieces.Additional information regarding the patient impact was being followed up from the facility.On follow-up it was reported that there were no patient or staff impact.There was no device fragment in the patient.

• 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: 21737967
• Report Number: 1625507-2025-01176
• Device Sequence Number: 18326569
• Product Code: HBE
• UDI-Device Identifier: 00763000084929
• UDI-Public: 00763000084929
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 04/01/2025

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: ASMC
• Device Catalogue Number: ASMC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2019
• 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