SYMMETRY VERITY

Description of Event or Problem

THE CUSTOMER ALLEGED THAT DURING THE OPERATION ACDF( ANTERIOR CERVICAL DISCECTOMY AND FUSION) C4-C6, AND WHILE USING THE MICROBALL NERVE RETRACTOR, ONCE PULLING OUT THE INSTRUMENT FROM THE NECK, IT WAS NOTED THAT THE TIP WAS MISSING. A THOROUGH LOOK IN THE FIELD OCCURRED, AND IT WAS NOT FOUND. THE INSTRUMENT WAS CLEANED AND KEPT PER PROTOCOL FOR THE DIRECTOR. AT THE END OF THE CASE, WHEN FINAL X-RAYS WERE TAKEN WITH THE C-ARM BOTH LATERALLY AND A/P, IT WAS NOT FOUND OR SEEN. IT WAS DETERMINED SAFE TO LEAVE IN THE PATIENT BY THE DOCTOR, AND CLOSURE OF SURGICAL SITE COMMENCED WITH CORRECT COUNT.

Additional Manufacturer Narrative

THE DEVICE CAN NOT BE RETURNED FOR EVALUATION AT THIS TIME AS IT IS NOT RELEASE FROM THE HOSPITAL. THE SALES REPRESENTATIVE FOR THE ACCOUNT WENT TO THE FACILITY TO REVIEW THE DEVICE AND TAKE PICTURES. THE PICTURES OF THE DEVICE CONFIRMED THAT THE TIP WAS BROKEN. HOWEVER, THERE WAS SIGNIFICANT BEND IN THE SHAFT THAT IS CONSISTENT WITH EXCESSIVE STRESS ON THE DEVICE. THE LOT NUMBER WAS ALSO CONFIRMED WITH THE PICTURES OF THE DEVICE. THE LOT NUMBER WAS TRACED TO A PURCHASE IN SEPTEMBER 2015. BASED ON THIS INFORMATION, IT CAN BE DETERMINED THAT THE DEVICE HAD BEEN IN USE FOR MORE THAN 7 YEARS PRIOR TO THE DAMAGE OCCURRING. BECAUSE THE DEVICE WILL NOT BE RETURNED NO FURTHER EVALUATION CAN BE COMPLETED. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED. USER FACILITY REPORT# (B)(4).