MAUDE Adverse Event Report: CONMED CONMED; ACCESSORIES,ARTHROSCOPIC

Catalog Number	C7312
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2025
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 customer reported that the device, c7312, clear flexible cannula threaded, 6.5 mm x 73 mm, was being used during an acl nail removal procedure on (b)(6) 2025 when it was reported, ¿the packing of the flexible cannula came off during surgery and entered the joint.The operation was completed after it was somehow removed.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Correction: d3 has been updated.Neither the device nor photographic evidence was provided.Therefore, the reported event cannot 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) 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).We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, c7312, clear flexible cannula threaded, 6.5 mm x 73 mm, was being used during an acl nail removal procedure on (b)(6) 2025 when it was reported, ¿the packing of the flexible cannula came off during surgery and entered the joint.The operation was completed after it was somehow removed.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, c7312, clear flexible cannula threaded, 6.5 mm x 73 mm, was being used during an acl nail removal procedure on 18oct25 when it was reported, ¿the packing of the flexible cannula came off during surgery and entered the joint.The operation was completed after it was somehow removed.".There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported to have been completed as planned.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Device return evaluation update: 19feb26 - visual examination of returned used device, item c7312, found cannula upper inner seal detached from cannula body and returned for the evaluation.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive force.Correction: d3 has been updated.Neither the device nor photographic evidence was provided.Therefore, the reported event cannot 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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 3 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame (b)(4) 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).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED; 525 french rd.; complejo industrial chihuahua; utica NY 13502
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas 11321; complejo industrial chihuahua; chihuahua 31136 ; MX 31136
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 23655288
• Report Number: 3007305485-2025-00190
• Device Sequence Number: 18655777
• Product Code: NBH
• UDI-Device Identifier: 10845854018873
• UDI-Public: (01)10845854018873(17)280513(10)1317960
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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: C7312
• Device Lot Number: 1317960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 02/13/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/07/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic