MAUDE Adverse Event Report: CONMED CORPORATION 6.5 X 73MM CLEAR FLEXIBLE CANNULA; ACCESSORIES,ARTHROSCOPIC

Catalog Number C7313

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

The involved shoulder cannula was not returned for evaluation.A photograph was provided of the "washer" which does show a small clear "washer" like object.In addition the lot information was not available.A 2-year review of complaint history shows no similar reports of "part broken off" received for this device family.During this same time frame, approximately (b)(4) units have been sold worldwide, making the rate of occurrence for this failure mode (b)(4).The failure mode is addressed in the risk document and risk analysis shows an acceptable risk level.To date, there has been no patient long term adverse effect resulting from this type of incident.This clear flexible cannula is used to create a surgical portal through which various surgical instruments may be passed during arthroscopic procedures.To reduce the risk of cannula breakage/tearing and patient injury, the instructions for use (ifu) for all similar disposable cannulas, 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 clear flexible cannula is supplied sterile and is considered single-use.Re-sterilization by any method is not recommended.Discarded at user facility.

Event Description

The customer reported that after successfully completing a repair of a shoulder injury arthroscopically; a small "washer" like object was noted floating within the joint.This "washer" was retrieved intact, with no reported issues.The cannulas and instruments were removed and the surgery was completed with no further complications or injury to the patient.

• Brand Name: 6.5 X 73MM CLEAR FLEXIBLE CANNULA
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5748766
• MDR Text Key: 49279998
• Report Number: 1017294-2016-00068
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2016

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 Catalogue Number: C7313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR