IBALANCE TKA, MODULAR T-HANDLE

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 COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER ERROR OF THE DEVICE DUE TO USER-APPLIED MECHANICAL FORCES.  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 (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-613-48 MODULAR T-HANDLE BROKE WHEN SURGEON WAS ASSEMBLING IT TO AN AR-613-45 IM ROD. NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SET. THIS WAS DISCOVERED DURING A TKA PROCEDURE ON (B)(6) 2022.