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

Model Number	PM800
Medical Device Problem Codes	Loss of Power (1475); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
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
Repair request initiated for device with the report of detachment of component.It was reported there was no patient involvement.Repair request escalated to product event due to customer indication that this report is a complaint.
Additional Manufacturer Narrative
Additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Initial report was submitted as detached bearings due to wrong coding, based on additional information, the customer allegation states that the device stops working.Hence, the event doesn't contain any injury and no past history of serious injury, the event is not reportable.H3:product analysis:evaluation determined that the pm800 does not run properly.The likely cause of failure is identified as ruptured exhaust hose.It was also noted that the device sounds rough, the bearings are worn, the housing is scratched, it is not possible disassemble the motor housing from the swivle, and the swivle got damaged during disassembly.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
Repair request initiated for device with the report of stops working.It was reported there was no patient involvement.Repair request escalated to product event due to customer indication that this report is a complaint.

• Brand Name: MOTOR MR8 PNEUMATIC
• 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: 20804910
• Report Number: 1625507-2024-01134
• Device Sequence Number: 13109561
• Product Code: HBB
• UDI-Device Identifier: 00643169912137
• UDI-Public: 00643169912137
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 04/11/2025

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: PM800
• Device Catalogue Number: PM800
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2021
• 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