VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING LEFT TKA ROBOTICALLY ASSISTED VELYS CASE- VELYS SAW HAND PIECE BROKE. NO HARM TO PATIENT.

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 THE SURGEON BELIEVED A DISTAL FEMUR FRACTURE MAY HAVE BEEN CAUSED BY BICORTICAL VELYS ARRAY PINS, WHICH CREATED A STRESS RISER. HE STATED THAT HE PLANNED TO PLACE PINS MORE DISTALLY AND UNICORTICALLY PER VELYS RAS STANDARD PIN PLACEMENT. ONE PATIENT WAS TREATED NONOPERATIVELY. ONE PATIENT WAS TREATED WITH A RETROGRADE NAIL. AS STATED IN THE REPORT, LOT NUMBERS WERE NOT AVAILABLE. PINS WERE DISCARDED AT THE CONCLUSION OF THE SURGERY. THE FRACTURES OCCURRED AT A LATER TIME. THERE WAS NO SIGNIFICANT DELAY. 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: SURGEON BELIEVES FRACTURE OF A DISTAL FEMUR MAY HAVE BEEN CAUSED BY BICORTICAL VELYS ARRAY PINS CAUSING STRESS RISER. HE MENTIONED THAT HE WOULD PLAN TO PLACE PINS MORE DISTAL AND UNICORTICAL AS PER VELYS RAS STANDARD PIN PLACEMENT. ONE PATIENT TREATED NON OPERATIVELY, ONE PATIENT TREATED WITH RETROGRADE NAIL. NO OTHER INFORMATION CURRENTLY AVAILABLE, NO LOT NUMBERS ARE AVAILABLE. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. J&J EQUIPMENT INCLUDED ALL INSTRUMENTS, IMPLANTS AND DISPOSABLE NECESSARY TO COMPLETE A CEMENTLESS ATTUNE PRIMARY KNEE WITH THE VELYS ROBOT. WAS THERE ANY REPORTED PATIENT OR USER HARM? UNKNOWN. WAS THERE A SIGNIFICANT DELAY? NO.

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 the surgeon believes fracture of a distal femur may have been caused by bicortical VELYS array pins causing stress riser. He mentioned that he would plan to place pins more distal and unicortical as per VELYS RAS standard pin placement. One patient treated non operatively, one patient treated with retrograde nail.