MAUDE Adverse Event Report: CONMED LARGO 5.5MM (I.D.) X 70MM SHOULDER CANN SET WITHOUT FENES; ACCESSORIES,ARTHROSCOPIC

Catalog Number 9718

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/10/2024

Event Type  malfunction  

Event Description

A customer reported that the 9718, 5.5mm (i.D.) x 70mm shoulder cann set without fenes device was being used during an unnamed procedure on (b)(6) 24, and ¿gasket came out of cannula in to patient shoulder, gasket was removed with shaver¿.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 four reports, regarding four devices, for this device family and failure mode.During this same time frame 145,103 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 0.00003.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 5.5MM (I.D.) X 70MM SHOULDER CANN SET WITHOUT FENES
• 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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 19201277
• MDR Text Key: 341388206
• Report Number: 1017294-2024-00045
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10845854013243
• UDI-Public: (01)10845854013243(17)250326(10)1344719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 9718
• Device Lot Number: 1344719
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic