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

Model Number	012421
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10613615
• Report Number: 1219602-2020-01498
• Device Sequence Number: 3004284
• Product Code: NBH
• UDI-Device Identifier: 03596010073655
• UDI-Public: 03596010073655
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Model Number: 012421
• Device Catalogue Number: 012421
• Device Lot Number: 2053558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention