SARNS STERNAL SAW II

Description of Event or Problem

THE CUSTOMER HAS HAD TO REPLACE THEIR STERNAL SAW PROTECTORS APPROXIMATELY TWENTY TIMES IN THE PAST YEAR DUE TO DEFORMATION OF THE FOOTPIECE. UPON INVESTIGATION OF THIS PROBLEM, IT WAS DISCOVERED THAT THE CUSTOMER HAS BEEN USING ANOTHER MFR'S BLADE WITH THE STERNAL SAW. THIS BLADE DOES NOT FIT EXACTLY INTO THE BLADE RETAINING MECHANISM (IT IS TOO LARGE FOR THE BALDE RETAINING MECHANISM). AS A RESULT OF THIS MISMATCH, THERE IS THE POSSIBILITY THAT THESE BLADES COULD BE EJECTED FROM THE BLADE RETENTION MECHANISM AND INTO THE THORACIC CAVITY DURING USE. THE CUSTOMER HAS NOT REPORTED ANY BLADES BEING EJECTED, NOR HAVE THEY REPORTED ANY INJURIES AS A RESULT OF THIS INCIDENT.