STRYKER

Additional Manufacturer Narrative

IT WAS REPORTED THAT DURING USE ON A SHOULDER ARTHROSCOPY PROCEDURE, THE REPROCESSED STRYKER FORMULA¿ BARREL BUR, 6-FLUTE (BLUE/BLUE)-USE W/CORE/CROSSFIRE/CROSSFIRE2 V1.0.04 OR PREV. 5.0MM RELEASED METAL SHAVINGS. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS REQUIRED TO RETRIEVE THE REPORTED METAL SHAVINGS. PER REPORT, "I WOULD ASSUME THEY DID A FLUSH W/ THE ARTHROSCOPY JOINT, AND NO PARTICLES REMAINED INSIDE OF THE PATIENT." THERE WAS NO SERIOUS INJURY OR ADVERSE PATIENT CONSEQUENCE REPORTED RELATED TO THIS EVENT. DUE TO THE REPORTED ISSUE OF THE DEVICE RELEASING METAL SHAVINGS AND THE REPORTED REQUIRED MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS RETURNED FOR EVALUATION AND THE COMPLAINT WAS CONFIRMED. THE LOT NUMBER ASSOCIATED WITH THE DEVICE WAS NOT REPORTED. A REVIEW OF THE REPROCESSING RECORD COULD NOT BE PERFORMED. A POTENTIAL ROOT CAUSE IS END-USER APPLYING SIDE FORCE TO THE SHAVER. A DEFINITIVE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE CONFIRMED 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 REPROCESSED STRYKER FORMULA¿ BARREL BUR WAS RELEASING METAL SHAVINGS DURING SHOULDER ARTHROSCOPY.