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

Model Number	MR8-T12MH25D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill was found to not be working mid way, and discovered that the drill bit had broken into 2 pieces.No patient impact reported.It was also reported that there was no intervention performed as a result of the event and no broken pieces of the reported product remain inside the patient's body.There was no procedure delay due to the event and the procedure was completed with backup product.On further follow-up it was reported that the procedure was endoscopy decompression, there is no recorded staff impact and the patient is doing good, alive without injury.
Additional Manufacturer Narrative
H3 product analysis: evaluation determined that the tip of the tool is fractured about 1.5 inches from the stem of the rest of the tool.The likely cause was identfied as the tool was most likely used with excessive force and possibly in a pushing or prying motion, which caused the tool to fracture where it did.It was also noted that there are also multiple dark colored rings on the stem of the tool, possibly meaning that the tool was in an attachment with failing bearings, that may have contributed to the tool fracture.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 DISSECTING
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
• 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: 20618666
• Report Number: 1625507-2024-01048
• Device Sequence Number: 7535169
• Product Code: HBF
• UDI-Device Identifier: 00763000514112
• UDI-Public: 00763000514112
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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-T12MH25D
• Device Catalogue Number: MR8-T12MH25D
• Device Lot Number: 0227273450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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