TRIMANO BEACH CHAIR KIT

Additional Manufacturer Narrative

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PROBABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A SUPPLIER PROCESS ISSUE; HOWEVER, DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO CONFIRM THE REPORTED EVENT. AS NO FURTHER INVESTIGATION WAS ABLE TO BE PERFORMED NO CHANGE IN HARM WAS IDENTIFIED. THIS COMPLAINT WILL BE INCLUDED IN TRENDING PER (B)(4).

Description of Event or Problem

ON 3/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1644 TRIMANO BEACH CHAIR KIT WAS MISSING THE STERILE SLEEVE. THIS WAS DISCOVERED UPON OPENING PACKAGE DURING A PROCEDURE, NO PATIENT WAS AFFECTED. ADDITIONAL INFORMATION REQUESTED.