MAUDE Adverse Event Report: CONMED CORP. ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number C08-65

Device Problems Break (1069); Detachment Of Device Component (1104); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The cannulas have not been received for evaluation.Upon receipt and completion of the device evaluation, a follow-up report will be submitted with the evaluation findings.

Event Description

The sales representative reported that during a rotator cuff repair using the adjustable retractor cannula, the surgeon attempted to insert the cannula in the anterior port.The entire distal tip of the cannula was folded in half with just a few millimeters of the forceps in front of the cannula.After struggling to insert the cannula, the surgeon pulled the cannula out.A piece of the distal tip of the cannula broke off and fell onto the floor.The tech then loaded another adjustable retractor cannula into the anterior port successfully.The surgeon tried to insert a third adjustable retractor cannula into the lateral port.The surgeon passed through the skin and initial deltoid area, then had a hard time entering the last bit of tissue.After a few attempts, the doctor was unable to see from the angle of the camera whether the cannula was inside the port and if it had broken through the tissue successfully.The surgeon attempted to pull the cannula back out of the port for re-insertion when the distal tip of the cannula broke off inside the port.The surgeon, cleaned up the area with a shaver and a wand, then removed the broken portion easily with a forceps.The surgeon cleaned the area, opened the portal a little larger, and successfully inserted the adjustable retractor cannula and completed the case with no further issue.A 2-minute delay was attributed to the issues the surgeon encountered during insertion of the cannulas.There was no report of any harm or impact to the patient.

Manufacturer Narrative

On (b)(6) 2016, conmed was notified that the damaged cannulas were disposed by the user facility.Photographs were provided which clearly shows a small piece on the wing of the distal tip of the cannula is torn off.This is a new device currently being monitored by new product quality engineering (npqe).A review of the device history record showed this lot was manufactured on 11-jan-2016 in a lot of (b)(4) units.The (b)(4).There were no discrepancies noted during manufacturing that could have caused or contributed to the reported problem.No other complaints have been received for this item and lot number combination.There have been two (2) other similar adverse event reports received for this device.To date, there has been no patient long term adverse effect report resulting from this type of incident.The adjustable retractor cannula is designed for general surgical use to maintain portals during insertion or extraction of instruments and implants.It is manufactured from silicone and easily introduced by grasping the wing with forceps and inserting into the incision.The risk analysis has been deemed acceptable per npqe monitoring.To reduce the risk of cannula breakage/tearing and patient injury, the instructions for use (ifu) provides the user with the following warnings, precautions and instructions for use: warnings: do not re-sterilize.Single use only.The ability to effectively clean and resterilize these single use devices have not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of these devices.It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use.Precautions inspect cannula prior to use to ensure they are in good physical condition.To avoid damage during use, do not use excessive force on cannula.Instructions for use: make a small incision with a scalpel.A kelly clamp or scissors can be used to aid in dissection and spreading of the tissue to accommodate the introduction of the adjustable retractor cannula.Fold the outer wings of the cannula in half and grasp with a pair of forceps.Insert and verify the cannula wing is through the portal.Release and retract the forceps when fully inserted.The adjustable retractor cannula is supplied sterile and is considered single-use.Re-sterilization by any method is not recommended.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORP.; 525 french rd.; utica NY 13502
• Manufacturer (Section G): CONMED CORP.; 525 french rd.; utica NY 13502
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5473892
• MDR Text Key: 39870129
• Report Number: 1017294-2016-00019
• Device Sequence Number: 1
• Product Code: NBH
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2016

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 Expiration Date: 01/10/2018
• Device Catalogue Number: C08-65
• Device Lot Number: 201601111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2016
• 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 Age: 45 YR