SYMMETRY SURGICAL

Additional Manufacturer Narrative

RETAINED PARTS (PART# 80-1531) FROM THE LOT (LOT# 823832) WERE REVIEWED AND DID NOT FIND ANY NERVE HOOKS THAT WERE MISSING THE 3.00 MM BALL TIP. THE REPORTED PART WAS DISCARDED BY THE HOSPITAL AND LOT NUMBER IS UNKNOWN. WITHOUT FURTHER INFORMATION THE ROOT CAUSE IS UNKNOWN. IF ADDITIONAL INFORMATION IS OBTAINED THAT IS PERTINENT TO THE INVESTIGATION OR PROVIDES ADDITIONAL DETAILS A FOLLOW-UP REPORT WILL BE PROVIDED. UNTIL SUCH TIME, THIS CAN BE SEEN AS THE FINAL REPORT.

Description of Event or Problem

PER THE COMPLAINANT, "WE JUST HAD 3MM BALL TIP PROBE 80-1531 BREAK OFF INTO THE PATIENT. CONFIRMED ALL PIECES REMOVED AND CONFIRMED BY X-RAY".