VERITY

Additional Manufacturer Narrative

UPON RECEIVING THE RETURNED DEVICE, IT WAS CONFIRMED THAT THE DEVICE WAS WITHIN CONFORMANCE FOR MATERIAL AND HARDNESS. THIS PARTICULAR CUSTOMER HAS REPORTED MULTIPLE ISSUES FOR BOTH WELL USED DEVICES AND BRAND NEW DEVICES. BASED ON THE AMOUNT OF ISSUES THIS CUSTOMER IS HAVING WITH THIS PRODUCT, IT CAN BE DETERMINED THAT SOMETHING IS OCCURRING DURING THE USE OF THE PRODUCT THAT IS CAUSING THEM TO BREAK. IF EXCESSIVE FORCE IS APPLIED TO THE TIP OF THE INSTRUMENT DAMAGE CAN OCCUR. THERE HAS BEEN A TOTAL (B)(4) SOLD OF ALL LOTS SINCE 2012 WITH 11 TOTAL COMPLAINTS RECORDED INVOLVING 17 DEVICES. 9 OF THE DEVICES ARE FROM THIS PARTICULAR CUSTOMER. (0.3%). THIS IS THE ONLY CUSTOMER THAT HAS REPORTED AN ISSUE WITH THE PRODUCT CODE THAT IS NEW. ALL OTHER COMPLAINTS THAT HAVE BEEN RECEIVED WERE AGED DEVICES. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THIS CAN BE SEEN AS THE INITIAL AND FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES IN ADDITIONAL PATIENT INVOLVEMENT OR THE NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE TIP BROKE OFF DURING USE AND FELL INTO THE PATIENT. THE PIECE WAS ABLE TO BE RETRIEVED WITH NO HARM TO THE PATIENT.