DYONICS

Additional Manufacturer Narrative

IT WAS REPORTED THAT A REPROCESSED DYONICS ELITE STONE CUTTER BUR, (MAROON/YELLOW) 4.0MM, BROKE DURING USE. PER REPORT, METAL SHAVINGS WERE NOTED IN THE SURGICAL SITE AND THE AREA WAS IRRIGATED UNTIL CLEAR. THERE WAS NO REPORT OF A SERIOUS INJURY, AN ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THIS INCIDENT. DUE TO THE REPORTED EVENT AND MEDICAL INTERVENTION REQUIRED TO CLEAR THE SURGICAL SITE OF METAL SHAVINGS, THIS MEDWATCH IS BEING FILED. THE DEVICE WAS RETURNED FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED. UPON INSPECTION OF THE RECEIVED DEVICE, NO ISSUES WERE OBSERVED. THERE WAS NO PHYSICAL DAMAGE TO THE DEVICE. THE DEVICE WAS DISASSEMBLED AND NO METAL SHAVES WERE OBSERVED. A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED AND INDICATED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE SURGICAL SITE REQUIRED IRRIGATION AFTER THE REPROCESSED DYONICS ELITE STONECUTTER BUR BROKE DURING USE AND ITS METAL SHAVINGS REACHED THE SURGICAL SITE.