STRYKER FORMULA¿ BARREL BUR, 6-FLUTE (RED/RED) 4.0MM

Additional Manufacturer Narrative

IT WAS REPORTED THAT A REPROCESSED STRYKER FORMULA BARREL BUR HAD EXCESSIVE METAL SHAVINGS DURING USE ON A PATIENT. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS. THERE WAS NO REPORTED IMPACT TO THE PATIENT OR TO THE PROCEDURE. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF SERIOUS INJURY, ADVERSE PATIENT CONSEQUENCE OR PROLONGED ANESTHESIA RELATED TO THE INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, RENEWAL IS FILING THIS MEDWATCH REPORT. THE SAMPLE WAS RETURNED FOR EVALUATION AND IT WAS CONFIRMED THAT THE DEVICE WAS REPROCESSED. THE REPORTED ISSUE THAT THE INNER SHAFT OF THE DEVICE CONTAINED METAL SHAVINGS WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT REPROCESSED STRYKER FORMULA BARREL BUR HAD EXCESSIVE METAL SHAVINGS.