MAUDE Adverse Event Report: MDT POWERED SURGICAL SOLUTIONS ATT MR8 ANGLED; MOTOR, DRILL, PNEUMATIC

Model Number	MR8-AA10DK
Medical Device Problem Codes	Overheating of Device (1437); Vibration (1674); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis: evaluation determined that the device was tested, and the temperature was measured to be 130.4f.The likely cause was identified as due to heavily corroded bearings, input and output drive shafts.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 procedure, drill was described as shuddering or jumping when applied to bone.Appears to be a distal b earing issue as has been previously noted at this site.This attachment was a warranty replacement for a previous incident.It was reported that there was no patient impact.It was also reported that there was no intervention performed, no damaged piece remained in the patient's body, and there was no delay in procedure.The procedure was completed with backup product(s).On further information it was stated as device overheating.

• Brand Name: ATT MR8 ANGLED
• Common Device Name: MOTOR, DRILL, PNEUMATIC
• 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: 21543766
• Report Number: 1625507-2025-00671
• Device Sequence Number: 7000377
• Product Code: HBB
• UDI-Device Identifier: 00763000440855
• UDI-Public: 00763000440855
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 03/07/2025

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-AA10DK
• Device Catalogue Number: MR8-AA10DK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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
• Patient Sex: Unknown