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

Model Number	MR8-15BA50D
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Repair request initiated for device with the report of not a complaint.No patient impact reported.Repair request escalated to a product event due to evaluation finding of the drill broken off in the tube.
Additional Manufacturer Narrative
H3:product analysis: pss unknown tool: 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.Product analysis:(b)(4).:evaluation determined that the tube is deformed.The likely cause of failure is inadequate preventative ma intenance.I was noted laser marking illegible/faded.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m r8-aa15, serial/lot #: (b)(6), ubd: , udi#: (b)(4).B3:date of event notification-08-11-2024.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.
Additional Manufacturer Narrative
Section d: additional info received about model and lot number of the tool.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.
Additional Manufacturer Narrative
H3:product analysis ((b)(4)): evaluation at emea service and repair center determined that tool is broken off in the tube.Further evaluation was required at the manufacturer¿s end; however, it could not be performed as the device was lost.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 DIAMOND
• 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: 21396193
• Report Number: 1625507-2025-00301
• Device Sequence Number: 20770244
• Product Code: HBE
• UDI-Device Identifier: 00763000490997
• UDI-Public: 00763000490997
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K020069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2025

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: MR8-15BA50D
• Device Catalogue Number: MR8-15BA50D
• Device Lot Number: 0228855440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 05/06/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 02/21/2025; 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Sex: Unknown