MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS TOOL MR8 BALL DISSECTING; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE

Model Number	MR8-9BA75
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: no evaluation will be performed as the device was discarded by customer.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 cranial biopsy procedure the drill bit as soon as it touched the bone immediately started getting extremely hot, producing smoke and wasn't cutting.There was no impact on the patient outcome.It was also reported that the surgeon switched to a different bit and proceeded with the case.
Additional Manufacturer Narrative
H3: evaluation of the device determined could not reproduce the reported malfunction of that extremely hot, producing smoke and wasn't cutting.It was also noted that mr8-9ba75 was returned in the used condition with the original packaging.The serial number and lot number are clearly visible.No oxide formation present and tool appears as expected.The tool was visually inspected under the microscope.A cut test was performed to compare the cutting efficiency and stability of the returned tool.The efficiency was evaluated based on the time taken for the tool to cut through the area, and the amount of heat generated, as felt by hand, by approximately the same amount of cutting.The stability was evaluated based on the presence or absence of uncontrolled vibration (chatter) during cutting.No noticeable differences in efficiency nor stability or signs of overheating were observed.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: TOOL MR8 BALL DISSECTING
• 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: 21110838
• Report Number: 1625507-2025-00026
• Device Sequence Number: 8682843
• Product Code: HBE
• UDI-Device Identifier: 00763000506544
• UDI-Public: 00763000506544
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K183515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2025

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: MR8-9BA75
• Device Catalogue Number: MR8-9BA75
• Device Lot Number: 0229456528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 05/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2024
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 59 KG