MAUDE Adverse Event Report: CONMED LARGO HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8.0 X 85MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	C7480
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the c7480, hex flex cannula with disposable obturator, 8.0 x 85mm, was being used during an unknown procedure on (b)(6) 2024 when it was reported, ¿the tip of the cannula breaks, causing fragments of the product to fall into the patient's joint cavity.It took a long time for the surgeon to remove the fragment.".There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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 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 c7480, hex flex cannula with disposable obturator, 8.0 x 85mm, was being used during an unknown procedure on 27feb24 when it was reported, ¿the tip of the cannula breaks, causing fragments of the product to fall into the patient's joint cavity.It took a long time for the surgeon to remove the fragment.".There was no report of injury, medical intervention, or hospitalization for the patient.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 for evaluation to date however, a photograph was provided.Review of the photograph however, does not show the tip of the cannula.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.A 2 year lot history review shows a total of 2 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 2 complaints, regarding 3 devices, for this device family and failure mode.During this same time frame 56,656 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 0.00005.Per the instructions for use, the user is advised the following: 1.Remove items from the sterile package using aseptic techniques.2.Place the obturator into the hex flex cannula.If using the reusable obturator, place the hex flex assembly over a switching stick for entry into the joint.Reusable obturator sold separately.3.Verify that the hex key on the obturator is engaged with the cap.4.Slowly screw the cannula clockwise when inserting it into the joint.Once in the correct position the cannula will engage the capsule, muscle, skin, etc.This will prevent the cannula from backing out of the joint.5.To remove the cannula from the joint, slowly screw the cannula counterclockwise.6.Properly discard the hex flex cannula after use per facility guidelines.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8.0 X 85MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18911338
• Report Number: 1017294-2024-00029
• Device Sequence Number: 20575649
• Product Code: NBH
• UDI-Device Identifier: 10845854018408
• UDI-Public: (01)10845854018408(17)280828(10)1330160
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: C7480
• Device Lot Number: 1330160
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic