REPL PRT AR-1600M HUB LEVER

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 DISTAL END OF THE HANDLE IS BROKEN AND MISSING A PIECE. THE BROKEN FRAGMENT WAS NOT RETURNED. NO FURTHER ABNORMALITY OBSERVED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

Description of Event or Problem

IT WAS REPORTED THAT A PIECE OF THE AR-16001408 HANDLE HAS BROKEN OFF AND THERE IS A SHARP PIECE OF HANDLE STICKING OUT SO IT IS NOT USABLE.