ARTHROSCOPIC SHAVERS

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. IT WAS CONFIRMED THE DEVICE WAS REPROCESSED. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS 367956. A REVIEW OF THE REPROCESSING RECORDS WAS PERFORMED. ALL PROCESSES WERE CONDUCTED AS REQUIRED PRIOR TO RELEASE. THERE WERE NO SHAVINGS ON THE RETURNED SAMPLE, FUNCTIONAL TESTS ON THE SAMPLE DETERMINED THAT THE SAMPLE FUNCTIONED ACCORDING TO PRODUCT DESIGN AND THE SAMPLE MET PRODUCT SPECIFICATIONS. WE HAVE NOT IDENTIFIED A MANUFACTURING DEFECT TO BE A CAUSE OR CONTRIBUTING FACTOR TO THE INITIAL REPORTED ISSUE. 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¿ EXCALIBUR SHAVER WAS BLOWING METAL CHUNKS OUT OF THE TIP DURING THE PROCEDURE. THE DEBRIS WAS REMOVED BY THE SURGEON USING IRRIGATION, ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT.