HEAT-CARRIER PLUGGER 1-2

Additional Manufacturer Narrative

SINCE THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH THE SAME PRODUCT WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

Description of Event or Problem

IN THIS EVENT IT IS REPORTED THAT A HEAT-CARRIER PLUGGER 1-2 BROKE DURING USE. OUTCOME IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION RECEIVED: WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT NO PATIENT WAS INJURED. THE BROKEN PARTS WERE NOT IN THE PATIENT'S MOUTH OR WERE REMOVED FROM THERE. NO FURTHER TREATMENT, EITHER MEDICAL OR SURGICAL, WAS REQUIRED. THE INSTRUMENT WAS USED APPROX. 1X DAILY BEFORE THE INCIDENT. INVESTIGATION SUMMARY: THE RETURNED HEAT-CARRIER PLUGGER 1-2 IS NOT BROKEN BUT WE CAN SEE THAT THE ALUMINUM CORE BEGAN TO OXIDIZE AT THE PLACE WHERE THE ACTIVE PART SIZE 1 IS CLAMPED. ULTIMATELY, THIS COULD HAVE LED TO A SEPARATION OF THE INSTRUMENT. THE BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. REPROCESSING PROCEDURE FOLLOWED BY THE CUSTOMER BEING UNKNOWN, WE CANNOT RULE ON ITS COMPLIANCE WITH MAILLEFER RECOMMENDATIONS. ROOT CAUSES ARE NOT IDENTIFIED. FOR INFORMATION, HAND INSTRUMENTS( LIKE HEAT-CARRIER PLUGGERS) CAN BE DEGRADED BY PEROXIDE HYDROGEN (H2O2) SOLUTIONS AND COMPONENTS MADE OF ALUMINUM CAN BE DEGRADED IN PRESENCE OF CAUSTIC SODA SOLUTIONS WITH MERCURY SALT.