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. COMPLAINT CONFIRMED. VISUAL EVALUATION CONFIRMS THE PERFORATION LINE IS MISSING FROM THE CAMERA DRAPE CAMERA HOLDER (P/N: C5706). NO DAMAGED WAS OBSERVED ON OTHER COMPONENTS. FURTHER EVALUATION WILL BE PERFORM UNDER AN NCR.

Description of Event or Problem

ON 11/15/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1644 TRIMANO BEACH CHAIR KIT HAD NO PERFORATION IN THE PART THROUGH WHICH THE ADAPTER OF THE TRANSPARENT STERILIZATION COVER WAS PASSED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. SURGEON COMPLETED CASE WITH A NEW DEVICE AND PATIENT WAS NOT AFFECTED.