GPS TKA PRO SOFTWARE

Description of Event or Problem

THERE WAS LESS THAN A 5 MINUTE SURGICAL DELAY WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT.

Additional Manufacturer Narrative

H10: TECHNICAL LOG REVIEWED. THERE WAS A DISCREPANCY BETWEEN THE PLANNED AND THE CHECKED NAVIGATED VALUES MOST LIKELY BECAUSE THE G TRACKER WAS NOT PROPERLY ENGAGED ON A REPRODUCIBLE FIXATION DURING THE FIRST DISTAL CUT GUIDANCE STEP. BECAUSE THE G TRACKER WAS NOT CORRECTLY CLIPPED, THIS IS CONSIDERED AS A BAD USE OF THE SYSTEM BY THE USER.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem

IT WAS REPORTED THAT DURING A COMPLEX CASE, (AMPUTATED RIGHT LEG, LATERAL PLATE FROM PROXIMAL FEMUR TO DISTAL FEMUR WITH SEQUELAE OF MALUNION LEFT FEMUR), THERE WERE 2 MINOR THINGS THAT NEEDED TO BE LOOKED AT. DISTAL FEMORAL CUT: WHEN THE DISTAL FEMORAL CUT WAS CHECKED, THERE WAS A CLEAR DISCREPANCY BETWEEN THE PLAN (M: 11MM, L: 12MM) AND THE CHECK (M:14MM, L:7MM). THE REP ASKED THE SURGEON TO GO BACK TO THE DISTAL CUT GUIDANCE AND IT CONFIRMED THE CHECKED NUMBERS. ALSO, THE SURGEON WAS ASKED TO MEASURE THE ACTUAL CUTS AND IT CONFIRMED THE CHECKED NUMBERS. THEREFORE THE REP ASSUMED THAT THE G TRACKER WAS NOT PROPERLY ENGAGED DURING THE INITIAL DISTAL CUT GUIDANCE. ULTIMATELY, IT HAS BEEN DECIDED TO RE-PERFORM THE CUT GUIDANCE AND PERFORMED A SUBSEQUENT CUT WHICH CORRECTED THE ISSUE (EXCEPT THE MEDIAL ASPECT OF THE RESECTION WHICH HAS BEEN OVER RESECTED DURING THE FIRST CUT).