MAUDE Adverse Event Report: CONMED CONMED; ACCESSORIES,ARTHROSCOPIC

Catalog Number	C7313
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, c7313, clear flexible cannula, 6.5 mm x 73 mm, was used during an unknown procedure on 4mar26 when it was reported, ¿during the surgery, it appeared that a piece of sealing became detached inside the cannula.The detached fragment entered the surgical site and was removed using a grasper.After removal, it was confirmed that no fragments remained inside the patient.Both the removed fragment and the device were immediately discarded in the operating room and are not retrievable.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate device causing a 5-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The customer reported that the device, c7313, clear flexible cannula, 6.5 mm x 73 mm, was used during an unknown procedure on (b)(6) 2026 when it was reported, ¿during the surgery, it appeared that a piece of sealing became detached inside the cannula.The detached fragment entered the surgical site and was removed using a grasper.After removal, it was confirmed that no fragments remained inside the patient.Both the removed fragment and the device were immediately discarded in the operating room and are not retrievable.¿.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was completed with an alternate device causing a 5-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.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.; 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: 24637088
• Report Number: 3007305485-2026-00042
• Device Sequence Number: 15926538
• Product Code: NBH
• UDI-Device Identifier: 10845854019948
• UDI-Public: (01)10845854019948(17)280701(10)1476060
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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): 04/03/2026

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: C7313
• Device Lot Number: 1476060
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic