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

Model Number	MR8-14BA20D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgical procedure of an expansive intracanal extradural dorsol d2-d6 lesion the tool broken and the ball which blew off the stem remained in the patient's body.On (b)(6) 2024 the fragment of broken tool was intercepted by mri control during the post-op.It was necessary to proceed with a re-intervention of the patient to remove the fragments from patient body on (b)(6) 2024.The procedure was completed with the reported product, broken pieces retrieved from patient's body and the tool was discarded.It was also reported that the patient was alive with no injury.
Additional Manufacturer Narrative
H3: product analysis: no conclusion can be drawn 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: TOOL MR8 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: 20180812
• Report Number: 1625507-2024-00629
• Device Sequence Number: 8261907
• Product Code: HBE
• UDI-Device Identifier: 00763000490232
• UDI-Public: 00763000490232
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MR8-14BA20D
• Device Catalogue Number: MR8-14BA20D
• Device Lot Number: 0227402880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown