ARC WRIST TOWER TRAY 1 OF 2

Additional Manufacturer Narrative

THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND.

Description of Event or Problem

DURING THE PRE-OP PHASE OF A WRIST ARTHOSCOPY SURGERY, AN "OPEN BOX FAILURE" WAS FOUND AND RESULTED IN A 20 MINUTE DELAY OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND NO ALTERNATE DEVICE WAS USED. IT WAS REPORTED THAT THERE WAS NO PATIENT OR USER IMPACT. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE "OPEN BOX FAILURE" HAVE BEEN MADE TO NO AVAIL.

Additional Manufacturer Narrative

THE RETURNED ARC WRIST TOWER ASSEMBLY (PART NUMBER 10100001) WAS EXAMINED VISUALLY UNDER MAGNIFICATION. BATCH NUMBER 523151 WAS CONFIRMED ON ALL SUBCOMPONENTS OF THE ASSEMBLY. ALL SUBCOMPONENTS APPEARED CLEAN WITHOUT ANY DEFECTS OR BLEMISHES. ONE TRAY APPEARED TO HAVE SOME SCRATCHES OVER WORDS IN THE INSTRUCTION PANEL. FUNCTIONAL TESTING WAS PERFORMED. THE ARC WRIST TOWER TRAY 1 AND 2 WERE OPENED WITH SIDE LATCHES WITHOUT ANY ISSUES. ALL PARTS WERE PLACED IN THEIR RESPECTIVE LOCATIONS IN THE TRAY AND WERE ABLE TO BE REMOVED EASILY. THE TOWER WAS ABLE TO BE ASSEMBLED FULLY. THE TWO BOLTS ON THE BOTTOM ARM PLATE WERE FULLY TIGHTENED IN THEIR CLOSED POSITION. THEY HAD TO BE LOOSENED COUNTERCLOCKWISE TO BE ABLE TO ALLOW THE TOP UPPER ARM PLATE TO BE PLACED IN POSITION AND SECURED. IF THESE TWO BOLTS ARE NOT LOOSENED, THE UPPER ARM PLATE CANNOT BE SECURED IN PLACE. ALL OTHER PARTS WERE ABLE TO BE ASSEMBLED WITHOUT ANY PRIOR LOOSENING OF BOLTS OR SCREWS. NO DEFINITIVE CONCLUSION ON THE CAUSE OF THE REPORTED EVENT COULD BE MADE.