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

Catalog Number C7480

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: HEX FLEX CANNULA WITH DISPOSABLE OBTURATOR, 8.0 X 85MM
• Type of Device: 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
• MDR Text Key: 337744231
• Report Number: 1017294-2024-00029
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C7480
• Device Lot Number: 1330160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic