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

Model Number	MR8-ND13BA45DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3:product analysis :no conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may 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 decompression procedure drill bit sheared off.No patient impact reported.It was also reported that no damaged piece remained in the patient's body and 10 minutes of delay in procedure.The procedure was completed with backup product.Additional information regarding the patient impact was being followed up from the facility.
Additional Manufacturer Narrative
H3 product analysis: evaluation of the tool determined that the tool head fractured at stem near location of tube exit and head is heavily covered in bioresidue.The suspected root cause was identfied as the tool head became caked in biodebris, which reduced cutting efficiency and the user applied heavier side load to compensate, which led to tool breaking.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 CLEARVIEW
• 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: 21294796
• Report Number: 1625507-2025-00093
• Device Sequence Number: 15784934
• Product Code: HBE
• UDI-Device Identifier: 00763000513764
• UDI-Public: 00763000513764
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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-ND13BA45DC
• Device Catalogue Number: MR8-ND13BA45DC
• Device Lot Number: 0229716828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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 Sex: Unknown