SYMMETRY

Additional Manufacturer Narrative

CORRECTED THE LOT NUMBER TO: 00059028. UPON RECEIVING THE RETURNED DEVICE, IT WAS CONFIRMED THAT LOT NUMBER OF THE DEVICE WAS 00059028 WHICH WAS PURCHASED IN JUNE 2018. BY TRACING THE LOT NUMBER, WE WERE ABLE TO IDENTIFY THAT THE DEVICE HAD BEEN IN USE FOR APPROXIMATELY 5 YEARS, PRIOR TO THE REPORTED COMPLAINT. THE RETURNED DEVICE WAS CONFIRMED TO BE BROKEN BEFORE THE CURVE OF THE HOOK BEGINS. WHERE THE TIP BROKE OFF, THERE WAS NOTED TO BE DEFORMATION THAT IS INDICATIVE OF EXCESSIVE STRESS ON THE DEVICE. THERE HAS BEEN A TOTAL OF 5,024 SOLD OF ALL LOTS WITH TWO ADDITIONAL COMPLAINTS RECORDED FOR A SIMILAR OCCURRENCE. (0.05%) BASED ON THE REVIEW OF THE DEVICE AND THE REVIEW OF THE PRODUCT HISTORY, NO FURTHER ACTIONS ARE REQUIRED. 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 ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THE CUSTOMER ALLEGED THAT THE NEURO INSTRUMENT WAS BEING USED DURING AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION. THE MICOR TIP BROKE OFF AND FELL INTO THE PATIENT DURING USE. THE TIP WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THERE WAS NO HARM TO THE PATIENT.

Additional Manufacturer Narrative

THE DEVICE IS BEING RETURNED FOR EVALUATION. THE LOT NUMBER HAS NOT BEEN CONFIRMED AND PICTURES HAVE NOT BEEN PROVIDED. THERE HAS BEEN A TOTAL OF 5,024 SOLD OF ALL LOTS WITH TWO ADDITIONAL COMPLANT RECORDED FOR SIMILAR OCCURRENCES ( 0.05%) ONCE WE HAVE RETRIEVED THE DEVICE AND COMPLETED OUR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.