MAUDE Adverse Event Report: CONMED MPOWER®; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO6450M
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the investigation of the device has not been completed.A supplemental and final report will be filed following the completion of the device and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the pro6450m, mpower 2 battery sternum saw, was being used on 4feb26 and the ¿saw blade falls off mid case¿.Per further assessment it was reported the "saw blade fell off into the site.Was retrieved.¿ there was no report of impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
An evaluation of the returned device found that the saw blade does not fall off once tightened with wrench.The gearbox was loosened from motor, however, no damage found.Preventative maintenance is overdue.Preventative maintenance was completed on this repair order.Repair/evaluation completed.Final test completed and met all specifications.The service history was reviewed, and no prior data was found.A device history record (dhr) review found no abnormalities that would contribute to this reported event.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame 10,322 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: the mpower 2 handpieces shall be returned every 12 months for servicing.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.With the blade guard in the proper position, release the locking sleeve.It will snap into place, locking the blade guard to the handpiece.Make sure the blade is inserted inside the slot of the blade guard, not outside.Otherwise, damage or injury may occur.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: MPOWER®
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 24686317
• Report Number: 1017294-2026-00033
• Device Sequence Number: 9770969
• Product Code: HAB
• UDI-Device Identifier: 10845854012833
• UDI-Public: (01)10845854012833(11)171027
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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 Catalogue Number: PRO6450M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2017
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic