ARTHROSCOPIC SHAVERS

Additional Manufacturer Narrative

THE DEVICE IN QUESTION HAS NOT BEEN RETURNED FOR EVALUATION. IT CANNOT BE CONFIRMED THAT THE DEVICE WAS REPROCESSED. HOWEVER, THE LOT NUMBER WAS PROVIDED, AND A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THE REPORTED ISSUE WAS COULD NOT BE CONFIRMED, AS THE DEVICE WAS NOT RETURNED. THE USER FACILITY CONFIRMED THAT THE DEBRIS WAS FLUSHED FROM THE KNEE GENERAL ANESTHESIA WAS USED; THE PATIENT WAS UNDER ANESTHESIA LONGER THAN EXPECTED. THE FACILITY REPORTED THAT, "IT IS UNKNOWN AT THIS TIME IF THERE WAS ANY ADVERSE PATIENT CONSEQUENCE". THIS IS AN MDR REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED. A ROOT CAUSE COULD NOT BE DETERMINED HOWEVER, DUE TO THE REPORTED INCIDENT AND THE SUBSEQUENT NEED FOR SURGICAL INTERVENTION, THE MEDWATCH IS BEING FILED.

Description of Event or Problem

WE RECEIVED A REPORT INDICATING THAT A REPROCESSED ARTHREX COOLCUT¿ BONE CUTTER SHAVER LEFT DEBRIS IN THE KNEE. THE DEBRIS WAS REMOVED BY THE SURGEON USING IRRIGATION, ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.