MAUDE Adverse Event Report: CONMED POWERPRO; ARTHROSCOPE

Catalog Number	PRO6100
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A sales representative reported on behalf of a customer that the pro6100, powerpro electric ii modular handpiece device was used in an unnamed procedure on (b)(6) 2025, and ¿a senior surgeon was performing surgery when suddenly while drilling the drill got jammed and the handpiece went in the air and was about to collide on (b)(6) face which he tried to manage and save but still it struck him in the forehead where he got injured.The system became unsterile, and the surgery was delayed, and (b)(6) was taken for first aid and x-ray as well.¿.Per further assessment, "thereafter mri was also done.Currently the surgeon is fine and recovering.No other user nor patient was injured during the incident.".No further description of the injury was provided.The d4000, drive system will be listed as a concomitant device.There are no allegations filed against it.This report is being raised due to the reported forehead injury sustained by the surgeon.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Correction: block d3 has been updated.Additional manufacturer narrative: neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed and no relationship to this complaint was found.(b)(4).Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised that with the safety/direction button in the ¿forward¿ position, depressing the trigger operates the handpiece in the oscillate mode within a range of 270° clockwise and 270° counterclockwise, with a variable speed of 0 - 750 rpm.With the safety/direction button in the ¿reverse¿ position, depressing the trigger operates the handpiece in the counterclockwise direction.The speed is variably controlled by the trigger.A brief audible beeping tone indicates ¿reverse¿ direction when the handpiece is initially activated.Reaming and sawing attachments are not designed to be used in the screw, tap or oscillating drill modes.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro6100, powerpro electric ii modular handpiece device was used in an unnamed procedure on (b)(6) 2025, and ¿a senior surgeon ¿ was performing surgery when suddenly while drilling the drill got jammed and the handpiece went in the air and was about to collide on sir¿s face which he tried to manage and save but still it struck him in the forehead where he got injured.The system became unsterile, and the surgery was delayed, and sir was taken for first aid and x-ray as well.¿ per further assessment, "thereafter mri was also done.Currently the surgeon is fine and recovering.No other user nor patient was injured during the incident.".No further description of the injury was provided.The d4000, drive system will be listed as a concomitant device.There are no allegations filed against it.This report is being raised due to the reported forehead injury sustained by the surgeon.

• Brand Name: POWERPRO
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 23568230
• Report Number: 1017294-2025-00117
• Device Sequence Number: 18685137
• Product Code: HRX
• UDI-Device Identifier: 10845854013038
• UDI-Public: (01)10845854013038(11)190325
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K981269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Catalogue Number: PRO6100
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: D4000, DRIVE SYSTEM; D4000, DRIVE SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic