MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIV CANN 7MM/76MM LTX FREE (10) GREEN; ACCESSORIES,ARTHROSCOPIC

Model Number 012421

Device Problem Nonstandard Device (1420)

Patient Problem No Information (3190)

Event Date 09/08/2020

Event Type  Injury  

Event Description

It was reported that the white outflow cap on the side of the cannula keeps popping off from the pressure of the fluid in the joint.Even when you fully tighten it down it slips/pops off.You cannot over tighten the cap either or else it becomes loose as if the threads are stripped.This is a recurrent malfunction.The procedure was completed with a competitor device with a delay shorter than 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found that locating the tip of the cannula within the soft tissue will minimize the possibility of fluid extravasation into the tissue.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: UNIV CANN 7MM/76MM LTX FREE (10) GREEN
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10613615
• MDR Text Key: 209394141
• Report Number: 1219602-2020-01498
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010073655
• UDI-Public: 03596010073655
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 012421
• Device Catalogue Number: 012421
• Device Lot Number: 2053558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 04/02/2021
• Supplement Dates FDA Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention