TOWER PARTS ASSEMBLY

Additional Manufacturer Narrative

THE DEVICE WAS RECEIVED FOR EVALUATION. AS RECEIVED, THE ARC WRIST TOWER PIVOT JOINT AND PIVOT JOINT ROTATING PLATE( WOULD NOT LOCK INTO PLACE. THE PIVOT JOINT FEMALE HEX LOCK WAS STUCK IN THE PIVOT JOINT ROTATING PLATE. WHEN THE PIVOT JOINT WAS TOGGLED TO ROTATE THE PIVOT JOINT ROTATING PLATE, THE PIVOT JOINT EXTRACTION ROD WAS EXPOSED ALONG WITH THE INTERIOR SPRING. MANUFACTURING AND INSPECTION RECORDS COULD NOT BE REVIEWED AS DEVICE BATCH/LOT NUMBER IS UNKNOWN. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED DURING THE PROCEDURE, THE PIVOT JOINT SEPARATED FROM THE BASE LOCKING DISC. THE LEVER ARM WOULDN'T LATCH, SO THE ARM WOULD TOGGLED WHILE LOCKED. DUE TO THIS ISSUE, AN EXTRA SURGICAL TECH WAS BROUGHT IN TO HOLD THE TOWER IN PLACE. THIS ISSUE RESULTED IN A 15-20 MINUTE DELAY IN PROCEDURE. THE PATIENT REMAINED STABLE, AND THERE WERE NOT ADVERSE CONSEQUENCES TO THE PATIENT.