HU-FRIEDY MFG CO., LLC.

Additional Manufacturer Narrative

BREAKAGE DUE TO CRACK IN INSTRUMENT. THE OBSERVED CUTTING-EDGE DULLING AND LACK OF TIMELY RESHARPENING MAY HAVE CONTRIBUTED TO INCREASED FORCE APPLIED DURING CLINICAL USE, FURTHER PROMOTING CRACK PROPAGATION AND EVENTUAL FRACTURE. NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECT WAS IDENTIFIED.

Description of Event or Problem

CUSTOMER REPORTED THAT INSTRUMENT BROKE AND THE PATIENT STATED THEY SWALLOWED THE TIP/PIECE. PATIENT RECEIVED AN X-RAY AND THE INSTRUMENT PIECE WAS NOT VISIBLE ON X-RAY.