PUNCH, LARGE 2.75MM X 100MM, STRAIGHT

Additional Manufacturer Narrative

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON (B)(6) 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 CUSTOMER STATES THAT THIS DEVICE WAS RETURNED BUT IT COULD NOT BE LOCATED AT AN ARTHREX LOCATION. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS WEAR AND TEAR.

Description of Event or Problem

ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-31200 LARGE STRAIGHT TIP PUNCH SNAPPED AND WOULD NO LONGER OPEN OR CLOSE. THIS WAS DISCOVERED DURING AN ANKLE ARTHROSCOPY PROCEDURE ON (B)(6) 2022.