TRACTION BOOT ASSEMBLY TO ORTHOPEDIC SURGICAL TABLE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PROCEDURE A PATIENT'S FOOT FELL OUT OF THE TRACTION BOOT ASSEMBLY TO THEIR ORTHOPEDIC SURGICAL TABLE. THE PATIENT'S FOOT NEEDED TO BE REALIGNED IN THE BOOT ASSEMBLY CAUSING A PROCEDURE DELAY. NO REPORT OF INJURY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

Additional Manufacturer Narrative

A STERIS SURGICAL PROJECT MANAGER ARRIVED ONSITE TO INSPECT THE TRACTION BOOT ASSEMBLY TO THEIR ORTHOPEDIC SURGICAL TABLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SURGICAL TABLE AND TRACTION BOOT ASSEMBLY WERE FOUND TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED TO SERVICE. NO REPAIRS WERE REQUIRED. THE OPERATOR MANUAL (150832-354) STATES IN SEC. 3.4 "USING CARBON FIBER TRACTION UNIT AND ACCESSORIES; STEP 3. A. APPLY TRACTION BOOT ASSEMBLY (SEE FIGURE 3-4) TO PATIENT'S ANATOMY AND SECURE WITH HOOK AND LOOP FASTENER SYSTEM ATTACHED TO FOOT SUPPORT." A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THEIR TRACTION BOOT ASSEMBLY. THE USER FACILITY ACCEPTED, HOWEVER, THE DATE OF IN SERVICE TRAINING HAS YET TO BE SCHEDULED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.