MAUDE Adverse Event Report: CONMED LARGO 5.5MM (I.D.) X 70MM UNIVERSAL CANN SET WITH FENES; ACCESSORIES,ARTHROSCOPIC

Catalog Number 9704

Device Problem Material Fragmentation (1261)

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

Event Date 09/12/2023

Event Type  malfunction  

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.H3 other text : device not yet received.

Event Description

The sales representative reported on behalf of the customer, that the 9704, 5.5mm (i.D.) x 70mm universal cann set with fenes was being used during an arthroscopic rotator cuff procedure on (b)(6) 2023 date when it was reported ¿the surgeon was complaining that the 9704 cannula seemed tighter when inserting the trocar and shaver handpiece.During tissue resection, he noticed that a piece of plastic inside the shoulder, which he was able to remove.The plastic was from the seal in the cannula.I tested another cannula with the same lot number and it too felt tight so we will be sending the entire box back with the used, broken cannula.¿.It was also reported that the ¿surgery completed after plastic was removed.¿.As well as the same alternate device was used, and a two-minute delay was reported in the procedure.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Examination of the returned used product found cannula upper seal broken off.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 1 complaint, regarding 1 device, 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)(6).We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer, that the 9704, 5.5mm (i.D.) x 70mm universal can set with fenes was being used during an arthroscopic rotator cuff procedure on (b)(6) 2023 date when it was reported ¿the surgeon was complaining that the 9704 cannula seemed tighter when inserting the trocar and shaver handpiece.During tissue resection, he noticed that a piece of plastic inside the shoulder, which he was able to remove.The plastic was from the seal in the cannula.I tested another cannula with the same lot number and it too felt tight so we will be sending the entire box back with the used, broken cannula.¿ it w as also reported that the ¿surgery completed after plastic was removed.¿ as well as the same alternate device was used, and a two-minute delay was reported in the procedure.There was no report of injury, medical intervention, or extended hospitalization to the patient or user.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: 5.5MM (I.D.) X 70MM UNIVERSAL CANN SET WITH 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17833343
• MDR Text Key: 324459221
• Report Number: 1017294-2023-00090
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10845854019320
• UDI-Public: (01)10845854019320(17)280513(10)1317700
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9704
• Device Lot Number: 1317700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic