MICROPOWER SAGITTAL SAW DETACHABLE LEVER

Additional Manufacturer Narrative

TO DATE, AN INVESTIGATION OF THE RETURNED SAW HAS NOT BEEN COMPLETED BY CONMED LINVATEC. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT DURING USE OF THIS SAW TO PERFORM FUSION OF A METATARSAL, IT FAILED TO OPERATE PROPERLY. THIS EVENT RESULTED IN A SURGICAL DELAY. IN ADDITION, BECAUSE OF THE DELAY, RADIOGRAPHY WAS NO LONGER AVAILABLE AND THE SURGICAL PROCEDURE HAD TO BE CANCELLED. THERE WAS NO REPORT OF INJURY RELATED TO THIS EVENT.