LANTERN HIP

Description of Event or Problem

1ST NAVIGATION UNIT AND REFERENCE SENSOR (BOTH RETURNED) - AFTER SUCCESSFUL TIBIA REGISTRATION, USER FAILED TO COMPLETE MULTIPLE FEMUR MANEUVER ATTEMPTS, EVENTUALLY COMPLETING THE MANEUVER WITH UNSATISFACTORY RESULTS: SURGEON SAID RESPONSE NUMBERS WERE OFF (NOT WITHIN EXPECTED GENERAL RANGE). PADDLES DID NOT ALIGN WITH THE BONE. CUT BLOCK DID NOT DROP AS EXPECTED. SURGEON "REMOVED ALL" AND PERFORMED FEMUR AGAIN WITH SIMILAR POOR OUTCOME 2ND NAVIGATION UNIT AND REFERENCE SENSOR - SUCCESSFUL FEMUR ALIGNMENT AND CUT.

Additional Manufacturer Narrative

THE FIRST NAVIGATION UNIT AND REFERENCE SENSOR USED WERE RETURNED TO ORTHALIGN FOR EVALUATION BY AN ORTHALIGN ENGINEER. THE PADDLES AND CUTTING BLOCK WERE NOT RETURNED. THE RETURNED DEVICES WERE TESTED INDIVIDUALLY AND AS A SYSTEM, AND BOTH DEVICES EXHIBITED ISSUES WITH THE FEMUR MANEUVER. THIS FEMUR MANEUVER MALFUNCTION PORTION OF THE COMPLAINT IS CONFIRMED. THE NAVIGATION LOGS WERE REVIEWED AND THE REPORTED NUMBERS OUTSIDE OF THE EXPECTED RANGE WERE PRESENT, HOWEVER, THE UNEXPECTED NUMBERS COULD NOT BE REPRODUCED DURING TESTING. THEREFORE, THE ACCURACY PORTION OF THE COMPLAINT CAN NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. POTENTIAL ROOT CAUSES INCLUDE USER ERROR, BAD PINNING, AND INSTRUMENT WEAR. ORTHALIGN WILL CONTINUE TO MONITOR COMPLAINT DATA AND TAKE ACTION WHEN NECESSARY. NO FURTHER ACTION REQUIRED.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND EVALUATED BY AN ORTHALIGN ENGINEER. THE NAVIGATION LOGS WERE DOWNLOADED FOR REVIEW AND NO ANOMALIES RELATED TO ACCURACY WERE FOUND. GIVEN THE SYSTEM INPUTS CAPTURED IN THE LOG FILE, THE SYSTEM PRODUCED THE EXPECTED OUTPUTS. THE DEVICE UNDERWENT ACCURACY TESTING WITH IN HOUSE INSTRUMENTS. THE DEVICE PASSES ALL ACCURACY TESTING. THE COMPLAINT IS NOT CONFIRMED AS THE ISSUE CANNOT BE SEEN IN THE NAVIGATION LOG OR REPRODUCED. THE ROOT CAUSE CANNOT BE DETERMINED, BUT A POSSIBLE ROOT CAUSE IS USER ERROR. NO FURTHER ACTION REQUIRED .

Description of Event or Problem

SURGEON IS REPORTING THAT LEG LENGTH (LL) AND OFFSET (OS) NUMBERS SEEMED OFF.

Description of Event or Problem

SURGEON IS REPORTING THAT LEG LENGTH (LL) AND OFFSET (OS) NUMBERS SEEMED OFF.

Additional Manufacturer Narrative

AT THIS TIME THE PART HAS BEEN RETURNED TO ORTHALIGN FOR EVALUATION BY AN ORTHALIGN ENGINEER. AN INVEVSTIGATION INTO THE COMPLAINT WILL BE CONDUCTED AND A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION DETAILING WHETHER OR THE NOT COMPLAINT COULD BE CONFIRMED AND THE ROOT. CAUSE, IF POSSIBLE.