CAST REMOVAL SAW

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED A CAST REMOVAL SAW (TCC2SAW) MOTOR WAS BURNING AND THE SAW WAS NOT CUTTING. THE PRODUCT MALFUNCTION DID NOT RESULT IN PATIENT INJURY.

Additional Manufacturer Narrative

THE CAST REMOVAL SAW (TCC2SAW) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - THE CAST SAW WAS SCRAPPED OUT. THE BLADE WAS PUT ON INCORRECTLY. THERE WAS A WASHER MISSING BETWEEN THE BLADE SPACER AND THE NUT THAT RETAINS THE BLADE. THIS MAY HAVE LED TO THE BLADE NOT OSCILLATING CORRECTLY AND OVERHEATING THE MOTOR. THE COMPLAINT IS CONFIRMED. IT IS LIKELY THAT WHEN THE CUSTOMER RE-ASSEMBLED THE SAW WITH A DIFFERENT SAW HEAD, THE CUSTOMER INADVERTENTLY DID NOT REPLACE THE SPACER, WHICH CAUSED OPERATIONAL ISSUES OF THE SAW. ROOT CAUSE- THE EVALUATION OF THE RETURNED PRODUCT FOUND THAT A SPACER WAS MISSING AFTER THE SAW WAS REASSEMBLED BY THE CUSTOMER, CAUSING THE OPERATION ISSUES. THE COMPLAINT IS CONFIRMED WITH THE FAILURE FAMILY OF USER ERROR AND WITH THE FAILURE REASON OF POOR OR IMPROPER MAINTENANCE OF DEVICE.