MICROPOWER SAGITTAL SAW DETACHABLE LEVER

Description of Event or Problem

THE CUSTOMER REPORTED THAT AT THE START OF SURGERY FOR AN ACL RECONSTRUCTION, THIS SAGITTAL SAW WOULD NOT FUNCTION. THE USER REPORTED THAT THE CONSOLE DISPLAYED AN ERROR MESSAGE OF "TORQUE LIMITED". THE USER FACILITY EXCHANGED THIS SAW FOR ANOTHER AND EXPERIENCED THE SAME PROBLEM WITH TWO MORE SAGITTAL SAWS. FOLLOWING THE FACILITY OBTAINED A LARGE BONE DRILL TO HARVEST THE GRAFT AND COMPLETED THE SURGERY AS INTENDED WITHOUT INJURY OR FURTHER DELAY. THE HOSPITAL REPORTED A 3/4 HOUR DELAY IN SURGICAL TIME RELATED TO THIS PROBLEM.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC REC'D THIS SAGITTAL SAW HANDPIECE FOR INVESTIGATION AND CONFIRMED THE REPORTED PROBLEM. THE EVALUATOR TESTED THE HANDPIECE AND FOUND THAT IT STALLED CAUSING THE REPORTED ERROR MESSAGE. FURTHER INVESTIGATION DETERMINED THAT THE UNIT STALLED RELATED TO CAST STATOR AND COMMUTATOR DISK FAILURES ALONG WITH MOISTURE INTRUSION NOTED BY RUST-LIKE DEPOSITS ON THE INTERNAL COMPONENTS OF THE HANDPIECE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS DEVICE FOR FAILURES. THE CUSTOMER WILL BE CONTACTED WITH THIS INFO AND PROVIDED ADDITIONAL INFO ON CARING FOR THIS DEVICE. ADDITIONAL REPORT NUMBERS FILED RELATED TO THIS EVENT: 1017294-2008-00117, 1017294-2008-00118.