MINI JOINT DISTRACTOR/COMPRESSOR

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 KNOB DETACHED WHEN THE WELD BROKE. THE KNOB DETACHED BECAUSE THE WELD BROKE. THE THREADED PIN REMAINS INTACT. 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 THE AR-8970JD KNOB BROKE FOLLOWING PLACEMENT OF TWO 2.4MM GUIDE WIRES FOR TALONAVICULAR JOINT DISTRACTION WITH DEBRIDEMENT. THE KNOB WAS DROPPED OUTSIDE OF THE PATIENT, GUIDE WIRES WERE REMOVED AND A SMALL JOINT DISTRACTOR WAS USED IN ITS PLACE. THE TENSIONING KNOB WAS RETRIEVED FROM THE OPERATING ROOM FLOOR FOLLOWING CASE COMPLETION.