MAUDE Adverse Event Report: CONMED LARGO POWERPRO; TRAY, SURGICAL, INSTRUMENT

Catalog Number	PRO6042
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
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.H3 other text : device not yet received.
Event or Problem Description
The distributor reported on behalf of the customer that the device, pro6042 powerpro 5:1 high torque chuck attachment, 1/4 in.Was being used on (b)(6) 2024 and "the device disassembled during surgery.¿ per further assessment it was found that "what we meant by 'disassembled' is that the components came apart from their original position, leaving the coupling in two separate pieces, no fragment or part remained in the surgical site." there was no 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
The device has not been returned to date; however, photographic evidence has been provided.If the device is returned, at a later date, the investigation may be updated and reanalyzed.The photograph shows the device is in two pieces.Root cause cannot be determined, however, based upon evaluation of the review of drawing, photos, engineering input; a possible cause of this event could not be determined without evaluating the physical device.The service history was reviewed, and no prior data was found.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.(b)(4).Per the instructions for use, the user is advised the following: prior to each use, inspect all equipment for proper operation and ensure all attachments and accessories are correctly and completely attached to the handpiece.Attachments are factory sealed.Do not disassemble or lubricate.Damage will occur.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the device, pro6042 powerpro 5:1 high torque chuck attachment, 1/4 in.Was being used on 27sep24 and "the device disassembled during surgery.¿ per further assessment it was found that "what we meant by 'disassembled' is that the components came apart from their original position, leaving the coupling in two separate pieces,.No fragment or part remained in the surgical site." there was no impact or injury to the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: POWERPRO
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• 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: 22327011
• Report Number: 1017294-2025-00078
• Device Sequence Number: 8289009
• Product Code: FSM
• UDI-Device Identifier: 10845854018507
• UDI-Public: (01)10845854018507(11)230721
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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 Catalogue Number: PRO6042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic