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

Catalog Number C08-65

Device Problems Break (1069); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

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

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

The first damaged adjustable retractor cannula was reported to have been discarded at the user facility hence the device is not expected to be returned for evaluation.A second damaged cannula was returned for evaluation on 17-mar-2016.Visual inspection found the distal end of the cannula had broken off and the broken portion was not returned.This lot with the (b)(4) was manufactured on 25-nov-2015.A review of the device history record for this lot found no noted discrepancies during the manufacturing process that could have could or contributed to this type of damage to the cannula.Of the lot containing (b)(4) units, there were three (3) other similar complaints received for this item and lot number combination.A review of the complaint history for the device family shows there have been no serious injuries or death related to this reported problem.This is a new device and is very technique dependent.The risk analysis is being monitored by the new product quality engineer (npqe) and has been deemed as acceptable.No further action is planned at this time.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.To reduce the risk of cannula breakage/tearing and patient injury, the instructions for use (ifu) provides the user with the following warnings and 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.It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use.The adjustable retractor cannula is supplied sterile and is considered single-use.Re-sterilization by any method is not recommended.Do not re-sterilize.Single use only.The ability to effectively clean and re-sterilize these single use devices have not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of these devices.

Event Description

The user facility reported that during a shoulder arthroscopic rotator cuff repair procedure, the first adjustable retractor cannula was prepared for insertion and that the forceps was applied to the cannula but was not utilized for about 20 minutes.When the surgeon tried to insert the cannula into the patient, the distal tip disconnected and fell off.The second time, a new cannula was used and the cannula was compressed for a few seconds.The cannula was then inserted and worked fine until after several passes of the suture passer in and out of the cannula, the tip broke off.The broken piece was removed with no problems reported and discarded at the user facility.Using an alternate device, the arthroscopic rotator cuff repair procedure went on and other than a ten minute delay the surgery was otherwise completed with no further complications or serious injury to the patient.

• Brand Name: ADJUSTABLE RETRACTOR CANNULA 8.0MM X 65MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORP.; 525 french road.; utica NY 13502
• Manufacturer (Section G): CONMED CORP.; 525 french road; utica NY 13502
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5510158
• MDR Text Key: 41039691
• Report Number: 1017294-2016-00033
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2017
• Device Catalogue Number: C08-65
• Device Lot Number: 201511201
• Other Device ID Number: SEE H. 10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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: 59 YR