MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULA SMOOTH FLEX 6.5 X 72MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72200428
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, silvers of the inside of the cannula came off inside of the patient.One silver removed and saved with cannula for reported, the other silvers were "ground up with shaver".It is unknown if there was delay and back-up.No patient injuries were reported.
Additional Manufacturer Narrative
The complaint discussed use of a tissue and bone cutting device combined with a plastic flex cannula.This is not a typical combination.Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, concise investigation and evaluation are not possible without product to evaluate.If objective evidence, relevant information, package or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: CANNULA SMOOTH FLEX 6.5 X 72MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8445890
• Report Number: 1219602-2019-00337
• Device Sequence Number: 10851332
• Product Code: NBH
• UDI-Device Identifier: 03596010597052
• UDI-Public: 03596010597052
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 72200428
• Device Lot Number: 42818T127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1