MINI JOINT DISTRACTOR

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, THE THREADED SHAFT BROKE. THE THREADED SHAFT WAS MEASURED AND FOUND TO MEET DIMENSIONAL SPECIFICATIONS. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.

Description of Event or Problem

IT WAS REPORTED THAT DURING A LAPIDUS SURGERY THE THREADED PART BROKE WHEN THE SURGEON HAD OPENED THE DEVICE. IT WAS FURTHER REPORTED THAT NOTHING BROKE OFF AND THE PROCEDURE WAS FINISHED SUCCESSFULLY WITH ANOTHER DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.