ARTHROSCOPIC BUR

Additional Manufacturer Narrative

THE FACILITY REPORTED METAL SHAVINGS IN THE SURGICAL SITE. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ADVERSE PATIENT CONSEQUENCE, NO EFFECT ON THE PATIENT'S STABILITY, AND NO NEED FOR ADDITIONAL MEDICAL INTERVENTION AS A RESULT OF THE INCIDENT. THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. WE CONFIRMED THAT THE DEVICE HAD BEEN REPROCESSED. THE DEVICE WAS IN GOOD CONDITION, AND DID NOT CONTAIN EVIDENCE OF RESIDUAL METAL SHAVINGS. OUR INVESTIGATION COULD NOT CONFIRM THE REPORTED ISSUE, AND THEREFORE THE ROOT CAUSE OF THE FAILURE IS UNKNOWN AT THIS TIME. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT ALL PROCESSES WERE CONDUCTED AS REQUIRED, AND THAT THE DEVICE MET INSPECTION AND LUBRICATION REQUIREMENTS PRIOR TO PACKAGING AND RELEASE. HOWEVER, WE ARE FILING THIS MEDWATCH REPORT IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem

A STRYKER FORMULA¿ ROUND BUR LEFT METAL SHAVINGS IN THE PATIENT'S KNEE DURING THE PROCEDURE.