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

Model Number	012421
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during arthroscopy surgery, their s&n cannula trocars did not seem to fit inside the cannula.They felt as if the cannula was not wide enough for the trocar and pieces broke off in the joint when inserting the trocar in the cannula.The procedure was completed with the same device with no delay or other complications.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.No product identification information was provided and thus a manufacturing record review, complaint history review, instructions for use review, and risk management review could not be conducted.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.

• 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: 11202616
• Report Number: 1219602-2021-00168
• Device Sequence Number: 2384953
• Product Code: NBH
• UDI-Device Identifier: 03596010073655
• UDI-Public: 03596010073655
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• 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 Model Number: 012421
• Device Catalogue Number: 012421
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 01/20/2021
• 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: Required Intervention