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. THE COMPLAINT IS NOT CONFIRMED. ONE UNPACKAGED AR-8970JD WAS RECEIVED FOR INVESTIGATION. FUNCTIONAL TESTING IDENTIFIED THAT ALL MOVABLE COMPONENTS WERE ABLE TO BE MANIPULATED. THE KNOB AND ARM RACK COMPONENTS FUNCTIONED AS INTENDED. NO PROBLEM FOUND.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGERY THERE WERE TWO PROBLEMS. THE SCREW DRIVER FOR 4,5 MM SCREWS WITH THE GOLDEN TIP DIDN´T FIT IN THE CORTICAL SCREW AR-8545-XX PROPERLY. AND THE MINI JOINTS DISTRACTOR AR-8970JD JAMMED AND ONLY COULD EXTRACT, BUT NOT COMPRESS.