VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT A PATIENT WITH A LIGHT OSTEOPOROSIS SUFFERED A FEMORAL FRACTURE 2.5 WEEKS AFTER A TOTAL KNEE ARTHROPLASTY PROCEDURE PERFORMED WITH THE VELYS ROBOTIC ASSISTED SURGERY SYSTEM; THE FRACTURE OCCURRED WHEN SHE STOOD UP FROM A SEATED POSITION, AND THE SURGEON SUSPECTED IT WAS CAUSED BY THE HOLES MADE BY THE VELYS ARRAY PINS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: POPLITEAL ARTERIA INJURY WHILE USING VELYS DURING A KNEE ARTHROPLASTY. THE SURGEON EXPLAINED THAT THEY DID NOT USE RETRACTORS AS USUAL FOR A RECUT AND FACED A POPLITEAL ARTERIA INJURY. THEY MADE A SUTURE DIRECTLY ON THE ARTERIA TO STOP THE BLEEDING AND THE PATIENT HAD NO MAJOR HEMORAGIA, AND NO OTHER VASCULAR SURGERY NEEDED. ARTHERIOGRAPHY WAS DONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A FIFTEEN MINUTE DELAY. PATIENT RECEIVED SURVEILLANCE IN THE ICU FOR A NIGHT AND A PLATELET-INHIBITING AGENT.

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT: THE FRACTURE WAS CAUSED BY FAILURE TO CLEAR THE POSTERIOR ASPECT OF THE PS BOX. NETHER THE VELYS CUTS OR THE SAGITTAL SAW CUTS WERE THE BLAME.