VELYS PURESIGHT 4515-70-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10603295520146), received between Mar 24, 2022 and Apr 1, 2026 — classified as 68 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (50 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT VELYS BASE STATION AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED INTRA-OPERATIVE EVENT DURING A TOTAL KNEE ARTHROPLASTY. FOLLOWING THE ANTERIOR CORTEX ACQUISITION, AN ALERT INDICATED THAT THE FEMORAL CHECKPOINT NEEDED TO BE RECHECKED, PROMPTING THE SURGICAL TEAM TO RETURN TO THE FEMUR AND TIBIA CHECKPOINTS. ARRAYS WERE REPLACED, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. THE EVENT RESULTED IN A DELAY TO THE SURGERY, BUT THERE WERE NO REPORTS OF INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION, AND NO IMPACT TO THE EXPECTED SURGICAL OUTCOME WAS INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24753996 ↗
• MalfunctionFeb 26, 2026Unintended Movement

  IT WAS REPORTED THE DISTAL AND CHAMFER CUTS WERE OFF. CAMERA WAS NOT ALIGNING WITH ROBOT AND WAS OFF PLANE NEARLY 1CM WITHOUT ADJUSTMENTS. IT WASN'T ABLE TO BE CONFIRMED HOW OFF THE CUTS WERE. WE DID CONFIRM THE ARRAYS MOVED AT SOME POINT. ISSUE WAS OBSERVED DURING SURGERY. NO DELAY IN PATIENT TREATMENTS. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453565 ↗
• MalfunctionFeb 17, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT VELYS BASE STATION, VELYS SATELLITE STATION, AND VELYS ARRAY SET KNEE WERE INVOLVED IN AN EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE REPORTED ISSUE WAS THAT, IN THE FINAL LANDMARKING STAGE AFTER ANTERIOR CORTEX, THE SYSTEM PROMPTED THE USER TO REPEAT TIBIA LANDMARKING FOR ALL POINTS. THIS RESULTED IN A SURGERY DELAY OF APPROXIMATELY 5 MINUTES, WITH THE ACTION TAKEN BEING RE-LANDMARKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND THERE WAS NO NEGATIVE IMPACT OR HARM TO THE PATIENT. THE COMPLAINT DEVICES WERE AVAILABLE FOR REVIEW, AND NO FRAGMENTS WERE GENERATED DURING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363504 ↗
• MalfunctionJan 27, 2026Unintended Movement

  PROBLEM REPORTED: DURING CUTS, POSTERIOR PLANE UNREACHABLE, THEN IT WAS, THEN AN ERROR PREVENTED CUTS AGAIN. ARRAY MOVEMENT ERRORS WERE PRESENT AS WELL. REQUESTING FSE TO PULL LOG FILES: WAS THIS AN UKA OR TKA PROCEDURE? TKA. WHEN WAS THE ISSUE OBSERVED? DURING SURGERY. WHAT STEP WERE THEY ON WHEN THIS ISSUE OCCURRED? CUTS. TROUBLESHOOTING: UNK; NO SWITCH TO MANUAL TOOLS NECESSARY. IF ISSUE WITH CUTS IS REPORTED, IS ROBOT MOUNTED TO THE BED? UNK. PATIENT INVOLVEMENT? YES. WERE THERE REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION? NO. ARE PATIENT TREATMENTS DELAYED OR CANCELLED? NO. NEXT DAY OF SURGERY: UNK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192819 ↗
• MalfunctionJan 26, 2026Unintended Movement

  1ST CASE IT WAS REPORTED THAT AFTER A SYSTEM UPGRADE, ISSUES OCCURRED IN TWO OUT OF THREE CASES. IN THE FIRST CASE, THE ANTERIOR CHAMFER CUT WAS OFF BY A COUPLE OF MILLIMETERS, POSSIBLY DUE TO UNINTENDED ARRAY MOVEMENT, BUT NO RECUTS WERE REQUIRED AND THE PROCEDURE CONTINUED AS PLANNED WITH A CEMENTLESS IMPLANT. HERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED, AND NO MANUAL INSTRUMENTS OR JIGS WERE NEEDED TO COMPLETE THE PROCEDURE. 3RD CASE IS CAPTURED UNDER COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24183244 ↗
• MalfunctionJan 21, 2026Unintended Movement

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION PRODUCED INACCURATE CUTS. MOST FEMORAL CUTS WERE UNDER RESECTED BY ABOUT 4 MM, THE DISTAL FEMORAL CUT WAS SET FOR 5 MM BUT REMOVED LESS THAN 1 MM ON THE LATERAL SIDE, WHILE THE TIBIAL CUT WAS ACCEPTABLE. IT WAS REPORTED THAT FEMORAL CUTS HAD BEEN CHECKED WITH THE POINTER PRIOR TO CUTTING, THE SURGEON COMPLETED THE PROCEDURE MANUALLY. AN ARRAY MOVEMENT WAS SUSPECTED (TIMING UNKNOWN), AND THE ROBOT WAS NOT MOUNTED TO THE BED RAIL. THE ARRAY SET KNEE DEVICE ALSO HAD AN UNINTENDED ARRAY MOTION. THE DEVICES WERE OPERATED IN CONJUNCTION WITH THE ROBOTIC-ASSISTED SOLUTION BASE STATION DEVICE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136128 ↗
• MalfunctionJan 20, 2026Unintended Movement

  IT WAS REPORTED THAT VELYS BASE STATION, VELYS SATELLITE STATION, AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE COMPLAINT DESCRIBED AN ISSUE WITH ARRAY MOVEMENT, WITH THE SYSTEM EXHIBITING ONGOING PROBLEMS THAT PROMPTED A REQUEST FOR FIELD SERVICE ENGINEER SUPPORT TO ASSIST WITH TROUBLESHOOTING. THE EVENT OCCURRED INTRA-OPERATIVELY, AND THERE WAS NO REPORTED INJURY, MEDICAL INTERVENTION, OR DELAY IN PATIENT TREATMENT. NO PATIENT CONSEQUENCES OR INVOLVEMENT WERE IDENTIFIED FOR ANY OF THE PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119180 ↗
• MalfunctionJan 12, 2026Unintended Movement; No Apparent Adverse Event

  IT WAS REPORTED DURING A TIBIAL RESECTION THE SAWBLADE WAS FLOATING 4MM OFF THE CUT MEDIAL SURFACE OF THE TIBIA. THE CHECKPOINT ON THE TIBIA SAID OKAY. WHEN THE SAW WAS IN THE TIBIAL CUT PLANE, THE SURGEON PLACED THE POINTER ON THE SAWBLADE AND IT SAID 4.5MM ANTERIOR. WHEN PLACING THE POINTER ON THE BONE IT SAID THE PREVIOUS CUT WAS 0MM, INDICATING THE ARRAYS DID NOT MOVE. THE SURGEON RECALIBRATED THE SAWBLADE AND IT THEN MOVED TO THE CORRECT CUT PLANE AND THE PROCEDURE WAS COMPLETED WITH NO DELAYS OR IMPACTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036967 ↗
• MalfunctionJan 5, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THE CHECKPOINTS WERE SIGNIFICANTLY OFF-PLAN BY 4-5 MM, LEADING TO THE PROCEDURE BEING SWITCHED TO MANUAL MODE AFTER UNSUCCESSFUL RE-REGISTRATION ATTEMPTS. THE ARRAYS REPORTEDLY DID NOT MOVE, AND THE SURGERY WAS DELAYED BUT NOT CANCELLED. THERE WERE NO REPORTED INJURIES, MEDICAL INTERVENTIONS, OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967608 ↗
• MalfunctionJan 5, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT VRAS TKA FOR OA WITH THE ARRAY IN QUESTION. DURING THE SURGERY, ALTHOUGH THE DEVICE ARRAY WAS CONNECTED, IT CAME LOOSE WITH LIGHT FORCE. AND THEY TRIED TO CHANGE THE ARRAY INTERFACE, BUT THERE WERE NO IMPROVEMENTS. THE SURGEON USED ANOTHER NEW ARRAY FOR THE SURGERY WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE RELATED TO THE EVENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957978 ↗
• MalfunctionDec 4, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT VELYS BASE STATION, VELYS SATELLITE STATION, AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE EVENT INVOLVED THE ROBOT HAVING DIFFICULTY GETTING INTO PLANE, WITH POSSIBLE UNINTENDED ARRAY MOVEMENT DURING THE PROCEDURE. THE INFORMATION WAS RECEIVED SECOND HAND, AND LOG FILES WERE REQUESTED FOR REVIEW. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION WERE REPORTED, AND THERE WAS NO DELAY OR CANCELLATION OF TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714401 ↗
• MalfunctionDec 4, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT VELYS BASE STATION, VELYS SATELLITE STATION, VELYS SAW HANDPIECE, AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE ISSUE OCCURRED INTRA-OPERATIVELY WHEN THE SAW WAS SIGNIFICANTLY OUT OF PLANE FOR THE POSTERIOR FEMORAL CUT, SUSPECTED TO BE DUE TO FEMORAL ARRAY MOVEMENT. AS A RESULT, THE SURGEON COMPLETED THE CASE MANUALLY, LEADING TO A DELAY IN THE PROCEDURE. THERE WAS NO REPORTED INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION, AND NO IMPACT TO THE EXPECTED SURGICAL OUTCOME OR PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714348 ↗
• MalfunctionDec 2, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED HALFWAY THROUGH THE LAST CUT, THE ROBOT DROPPED; THIS CHANGED THE CUT ANGLE. THE ROBOT WAS CART MOUNTED. THE CUT WAS ROUGHLY FOUR MILLIMETERS (4MM) OFF; THE PROCEDURE WAS COMPLETED MANUALLY MINIMIZING TO TWO TO THREE MILLIMETERS (2-3MM) WITH CEMENT. THE PROCEDURE WAS DELAYED FOR ABOUT FIFTEEN (15) MINUTES; IT WAS NOTED THAT THE ARRAY MOVING CAUSED THE ROBOT ARM TO CHANGE ANGLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692025 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE VELYS SAW HANDPIECE, VELYS BASE STATION, AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED EVENT. DURING SETUP FOR A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE POINTER CHECK ACQUISITION WITH THE SAW HANDPIECE FAILED MULTIPLE TIMES, AND AN ERROR MESSAGE WAS DISPLAYED DURING CALIBRATION BEFORE THE PROCEDURE BEGAN. THE FRONT INTERFACE OF THE SAWHANDPIECE GETS LOSE - THIS LEADS TO A ROTATION. THIS IS CAUSING THE SAWARRAY TO BEND ONCE YOU CONNECT IT. MOST LIKELY THE RIGHT SIDE COULD NOT BE ACQUIRED ANYMORE. LEFT SIDE IS STILL GOOD. THE EVENT OCCURRED DURING THE FIRST USE OF THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT OR CLINICAL CONSEQUENCE, AS THE ISSUE OCCURRED PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691637 ↗
• MalfunctionDec 2, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT VELYS SAW HANDPIECE, VELYS BASE STATION, AND VELYS ARRAY SET KNEE WERE INVOLVED IN A REPORTED EVENT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. THE FAILURE OCCURRED WHEN THE POINTER DID NOT DETECT THE ARRAY ON THE SAW, PREVENTING CALIBRATION OF THE SAW BLADE. THE FRONT INTERFACE OF THE SAWHANDPIECE GETS LOSE - THIS LEADS TO A ROTATION. THIS IS CAUSING THE SAW ARRAY TO BEND ONCE YOU CONNECT IT. MOST LIKELY THE RIGHT SIDE COULD NOT BE ACQUIRED ANYMORE. LEFT SIDE IS STILL GOOD. THE ISSUE WAS ENCOUNTERED DURING THE CALIBRATION STEP, RESULTING IN A DELAY TO THE SURGICAL PROCEDURE. THE USER REPLACED THE ARRAY AND THEN THE SAW HANDPIECE, AFTER WHICH CALIBRATION WAS SUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT, INJURY, OR IMPACT TO THE EXPECTED SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23691616 ↗
• MalfunctionNov 19, 2025Unintended Movement; No Apparent Adverse Event; Unintended Movement; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING INSPECTION OF INSTRUMENTS SET, PHYSICAL MISALIGNMENT OF SAWHAND PIECE HAS BEEN DETECTED. THE FRONT PORTION OF THE HANDPIECE IS SLIGHTLY TWISTED. IT ATTACHES WITHOUT ISSUE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23592878 ↗
• MalfunctionNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE VELYS KIT FAILED TO PASS THE SAW CALIBRATION. THE VELYS WAS RESTARTED BUT HAD THE SAME PROBLEM. A NEW KIT WAS OPENED AND COULD PROCEED WITH THE CASE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497333 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, WHEN MEASURING THE CHECKPOINT ON THE TIBIAL CUT, IT WAS OFF BY 20MM. IT WAS UNSURE IF THERE WAS ARRAY MOVEMENT DURING THE PROCEDURE. IT WAS NOTED THAT THE ARRAY WAS DIFFICULT TO SEE WHILE DOING THE RANGE OF MOTION STEP OF THE PROCEDURE. THEY TRANSITIONED TO MANUAL INSTRUMENTATION TO COMPLETE THE SURGERY SO THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. THERE WAS NO DELAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294731 ↗
• MalfunctionOct 10, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PRE-OPERATIVELY WHEN THE ARRAY KIT WAS OPENED, THE IR EYE CLOSEST TO THE CONNECTION POINT ON THE FEMORAL ARRAY FELL OFF THE ARRAY. ANOTHER KIT WAS USED AND COMPLETED THE CASE WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23270283 ↗
• MalfunctionAug 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE ROBOTIC-ASSISTED SOLUTION ARRAY CLAMP DEVICE WAS FOUND TO HAVE BROKEN WHILE OPERATING IN CONJUNCTION WITH THE ROBOTIC-ASSISTED BASE STATION DEVICE AND THE ROBOTIC-ASSISTED SATELLITE STATION DEVICE. IT WAS FURTHER REPORTED THAT THE ROBOTIC ASSISTED BASE STATION WAS UNDER-RESECTING AND MOVING OUT OF PLANE. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839250 ↗
• MalfunctionJul 2, 2025Unintended Movement; Patient Device Interaction Problem; Unintended Movement; Patient Device Interaction Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA) ON (B)(6) 2025. WHEN PERFORMING THE DISTAL CUT OF THE FEMUR, THE SURGEON WAS NOT ABLE TO COMPLETE THE CUT WITH THE ROBOT DUE TO A CONFLICT BETWEEN FEMUR ARRAY AND SAW. THERE WAS A LOSS OF VISIBILITY PLUS SOME PHYSICAL CONFLICT. THE SURGEON FOCUSED ON PUTTING THE PINS AT 45 DEGREE OR LOWER, BUT THE ARRAY ITSELF WAS PUT HIGH NOT IN ALIGNMENT WITH THE FEMUR. THE SURGEON WAS STILL ABLE TO DO THE MAJORITY OF THE CUT WITH THE ROBOT AND COMPLETED THE MOST INTERNAL PART OF THE CUT (CLOSEST TO THE KNEE CENTER) MANUALLY. THE FINAL LEG ALIGNMENT DID MATCH THE PLAN AND THE SURGEON WAS SATISFIED WITH THE CLINICAL RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386658 ↗
• MalfunctionJun 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE THE SURGEON REACQUIRED TIBIAL LANDMARKS AFTER TIBIAL ARRAY MOTION WAS DETECTED PRIOR TO THE TIBIAL CUT. HE NOTED THAT THE FEMORAL SIZE APPEARED TO HAVE CHANGED FROM A SIZE SEVEN TO A SIZE EIGHT, DESPITE THE FEMORAL SIZE ONLY RELYING ON FEMORAL LANDMARKS. INACCURATE CUTS OF AN UNKNOWN AMOUNT WERE OBSERVED. THE REBOT WAS NOT MOUNTED TO THE BED. THIS EVENT OCCURRED WHILE USING THE 2X VELYS BASE STATION DEVICES, VELYS SATELLITE STATION DEVICE AND THE VELYS ARRAY SET KNEE DEVICE. THERE WERE NO REPORTS OF A DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bone Notching

  MAUDE report 22318752 ↗
• MalfunctionJun 13, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A VELYS UKA CASE, THE SURGEON DETECTED THAT THE FEMORAL ARRAY MOVED PRIOR TO MAKING ANY RESECTIONS ON THE FEMUR. THE TIBIAL RESECTIONS WERE NOT AFFECTED AND WERE PERFORMED USING THE SYSTEM. THE SURGEON WAS INFORMED THAT THEY COULD BAIL TO MANUAL INSTRUMENTED UKA USING THE INTUITION INSTRUMENTS, BUT THE SURGEON WANTED TO COMPLETE THE CASE USING THE VELYS SYSTEM. DUE TO THE ARRAY MOTION, THE SURGEON RESTARTED THE SOFTWARE AND USED THE INTUITION KIT TIBIAL SPACER BLOCK IN ORDER TO REACQUIRE THE TIBIAL LANDMARKS. BECAUSE THE FEMUR WAS INTACT, THEY WERE ABLE TO REACQUIRE THOSE LANDMARKS ON INTACT ANATOMY. THE SURGEON COMPLETED THE FEMORAL RESECTIONS WITHOUT ISSUE USING THIS TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202550 ↗
• MalfunctionJun 4, 2025Unintended Movement; Unintended Movement

  THIS IS REPORT 2 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE POST ANTERIOR CORTEX, IT WAS OBSERVED THAT THE VELYS SATELLITE STATION DEVICE SCREEN FROZE WHILE IN USE. THE USER TRIED MOVING THROUGH THE PROGRAM ONCE IT FROZE WHILE USING THE PEDAL AND CLICKING THE ARROW. IT WOULD MAKE THE NOISE LIKE IT WAS GOING TO THE NEXT CUT OR PLANNING SCREEN BUT THE SCREEN NEVER CHANGED. THE USER THEN POWERED OFF THE ROBOT AND POWERED IT BACK ON. THE ROBOT WAS NOT MOUNTED. AFTER REBOOTING, THE CUTS WERE OFF BUT IT FELT THAT IT WAS JUST A COINCIDENCE AND THAT THE ARRAYS HAD PROBABLY MOVED AFTER RE-REGISTERING THE CHECKPOINTS. IT WAS UNKNOWN IF THE ROBOT WAS MOUNTED TO THE BED. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH THE ROBOTIC ASSISTED BASE STATION DEVICE AND THE ARRAY SET KNEE DEVICE. THE PROCEDURE WAS PROLONGED FOR AN UNSPECIFIED AMOUNT OF TIME. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143427 ↗
• MalfunctionMay 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THE FEMORAL ARRAY LOOSENED DURING THE OPERATION. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106403 ↗