#23/UNC12 EXPRO #7 HANDLE

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE THE TIP OF THE PROBE BROKE IN PATIENT'S MOUTH AND THE PATIENT MIGHT HAVE SWALLOWED IT. A RADIOGRAPH WAS TAKEN TO LOCATE THE TIP AND THEY FOUND NO EVIDENCE OF THE TIP. PATIENT DECLINED ANY FURTHER MEDICAL INTERVENTION.

Additional Manufacturer Narrative

THE DEVICE SUBJECT OF THE REPORTED EVENT WAS RETURNED TO HU-FRIEDY FOR EVALUATION. THE PROBE TIP WAS LIKELY SUBJECTED TO EXCESSIVE FORCE DURING USE, LEADING TO THE BREAKAGE OF THE POINT. THIS INDICATES A USE-RELATED FAILURE MECHANISM. THE DEVICE HISTORY RECORD FOR THE SUBJECT LOT WAS REVIEWED. RETURN RATES AND COMPLAINT RATES ARE LOW, NO FURTHER ACTION WILL BE TAKEN.