DYONICS

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE SLEEVE OF THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE OFF INTO THE PATIENT DURING AN UNIDENTIFIED ORTHOPEDIC PROCEDURE. PER REPORT, THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED THROUGH USE OF GRASPERS. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PROLONGED ANESTHESIA, A SERIOUS INJURY OR AN ADVERSE PATIENT EVENT RELATED TO THE REPORTED INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. IT CANNOT BE CONFIRMED IF THE DEVICE IS A REPROCESSED DEVICE. A 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 SLEEVE OF THE REPROCESSED DYONICS FULL RADIUS BLADE BROKE OFF INTO THE PATIENT DURING AN UNIDENTIFIED ORTHOPEDIC PROCEDURE. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT THROUGH USE OF GRASPERS.