HU-FRIEDY MFG CO., LLC.

Additional Manufacturer Narrative

THE FAILURE IS MOST LIKELY ASSOCIATED WITH CRACK DEVELOPMENT AND PROPAGATION DUE TO MECHANICAL FATIGUE AND/OR STRESS ACCUMULATED DURING USE. 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 INDICATION OF MANUFACTURING DEFECT WAS IDENTIFIED.

Description of Event or Problem

DEALER REPORTED THAT CUSTOMER STATED THE INSTRUMENT BROKE OFF WITHIN THE PATIENTS MOUTH. THE BROKEN PART COULD NOT BE REMOVED AND PATIENT NEEDED AN X-RAY AT THE ORAL SURGEON. THE BROKEN PIECE WAS VISIBLE ON THE X-RAY.