VELYS 4515-70-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10603295519140), received between Mar 14, 2022 and Sep 22, 2026 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (11 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Failure to Cut

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure, it was observed that the Robotic Assisted Saw Handpiece Device would register but when in position to cut there was no power and VELYS SAW BLADE would not move. It was confirmed that the light was green, but the saw would still not move. It was reported that a new tray was opened and a new saw was used. It is unknown of the robot was mounted to the surgical bed. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853123 ↗
• MalfunctionSep 17, 2026Failure to Cut

  It was reported that during Tibial resection it was observed that the Robotic Assisted Saw Handpiece Device and VELYS SAW BLADE device was not working even when the Robotic Assisted Saw Interface Device (SASI) was in cut plane for resection. It was further observed that 2X Robotic Assisted Array Clamp Devices were loose. It was not reported if there was any harm to the patient or surgical delay. No additional information was provided.This is report 2 of 3 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802466 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  It was reported that prior to surgery the right side pointer check was failing. Also the customer was facing difficulties while inserting the saw blade into saw handpiece device.Was there any reported patient or user harm? Unknown.Was there a significant delay? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777208 ↗
• MalfunctionSep 14, 2026Device-Device Incompatibility

  It was reported that the Robotic-Assisted Solution oscillating saw blade device was faulty and did not fit in the saw handpiece device. A new blade was opened and fitted into the handpiece. The event occurred prior to the patient arriving in the room. There was no delay in surgery. 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 50754992 ↗
• MalfunctionSep 14, 2026Device-Device Incompatibility

  It was reported that during surgery, while trying to execute the first cut on the tibia, the saw blade device entered the first plunge cut but became completely loose and detached from the saw handpiece device. According to the reporter, the blade and saw handpiece device had been registered correctly at the start of the case and the clasp on the top of the saw was fully seated. The blade device was reattached and checked and it was fine for the rest of the case. There was no harm to the patient and the case was delayed by about 10 seconds due to the event. There were no reports of injuries, medical intervention or prolonged hospitalization.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754691 ↗
• MalfunctionAug 14, 2026Failure to Cut; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253229 ↗
• MalfunctionApr 1, 2026Failure to Cut

  IT WAS REPORTED THE DISTAL FEMUR CUT WAS GOOD BUT THE ANTERIOR CUT WERE OFF. CASE WAS COMPLETED MANUALLY. ISSUE OCCURRED ON THE ANTERIOR CUT STEP. NO PATIENT TREATMENTS WERE DELAYED OR CANCELLED. NEXT DAY OF SURGERY: (B)(6) 2026. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24752488 ↗
• MalfunctionMar 4, 2026Unintended Movement

  IT WAS REPORTED THE SAW BLADE HAD TOO MUCH PLAY IN THE SAW HANDPIECE. THE SAW BLADE WAS SWAPPED OUT BEFORE CUTS. THE PROCEDURE WAS COMPLETED WITH A TWO MINUTE DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512257 ↗
• MalfunctionFeb 26, 2026Device-Device Incompatibility; Unintended Movement

  POSTOPERATIVELY TO A TKA, THE SAW WILL NOT LOCK ON THE SAW BLADE AND THE SAW BLADE GETS LOOSE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THERE WAS NO TREATMENT DELAY OR CANCELLATION. NEXT DAY OF SURGERY: IF KNOWN (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454771 ↗
• MalfunctionJan 6, 2026Unintended Movement; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE THE SURGEON STARTED THE TIBIAL RESECTION AND WHEN THEY CAME BACK TO COMPLETE THE CUT THE SAWBLADE WAS FLOATING 4MM OFF OF 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 SAW BLADE, AFTER WHICH THE BLADE RETURNED TO THE CORRECT CUT PLANE. THERE WERE NO PATIENT CONSEQUENCES AND NO SURGICAL DELAYS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976832 ↗
• MalfunctionDec 24, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED SAW BLADE DEVICE HAD SAW DRIFT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887666 ↗
• MalfunctionDec 23, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED DURING A TKA PROCEDURE ON (B)(6) 2025, THE SAW BLADE GOT STUCK IN THE TIBIAL BONE AND CAME OUT OF THE SAW HANDPIECE. THEY TRIED TO REINSERT THE SAW BLADE INTO THE SAW, BUT THE LEVER WOULDN¿T LOCK THE BLADE INTO PLACE. THEY REPLACED THE SAW AND COMPLETED THE SURGERY WITHOUT FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23876272 ↗
• MalfunctionDec 5, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  IT WAS REPORTED THE SAW BLADE CLAMP BROKE OFF BEFORE A CASE AFTER IT WAS DROPPED. THE PROCEDURE WAS NOT DELAYED OR CANCELLED AND THERE WERE NO REPORTS OF PATIENT INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728493 ↗
• MalfunctionDec 4, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, THE SURGEON WAS STRUGGLING THROUGHOUT THE PROCEDURE DUE TO THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT BEING LOOSE AT THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE. AFTER THE PROCEDURE, THREE ADDITIONAL SASIS WERE FOUND TO HAVE LOOSE SPRINGS. ADDITIONALLY, WHEN THEY OPENED ONE OF THEIR TRAYS, THE VELYS SAW BLADE HANDLE WAS LAYING IN THE TRAY AND SEPARATED FROM THE SAW. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718704 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT THE CLAMP ON THE ROBOTIC-ASSISTED SOLUTION OSCILLATING SAW BLADE DEVICE BROKE OFF AFTER PROCESSING IN THE STERILIZING DEPARTMENT. IT WAS NOTED THAT THE SAW WAS NOT DROPPED. THE EVENT OCCURRED BEFORE A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE. THE DEVICE WAS OPERATED IN CONJUNCTION WITH THE ROBOTIC ASSISTED SAW HANDPIECE 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 23637792 ↗
• InjuryNov 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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.

  Patient problems: Vascular Dissection

  MAUDE report 23585660 ↗
• MalfunctionJul 21, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THE 1ST CASE THE SAW CALIBRATION MAY BE OFF ¿ ALL FEMORAL CUTS WERE SYSTEMATICALLY ALL 1 TO 1.5MM OFF WHERE WOULD BE EXPECTED WHEN THEY WERE CHECKED AFTER THE RESECTIONS. THERE WAS AN ADDED 5 MINUTES TO SURGERY TIME, NO FURTHER PATIENT IMPACT AND THE IMPLANTS SAT WELL AT FINAL TRIAL AND THE SURGEON WAS HAPPY. THE PATIENTS' KNEE WAS STILL FULLY BALANCED; NO INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553666 ↗
• InjuryFeb 26, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING A PROCEDURE WITH AN ATTUNE TKA PS FIXED BARING A LATERAL CONDYLAR FRACTURE OCCURRED. THE PRIMARY CUTS WERE PERFORMED BY THE VELYS SYSTEM. AFTER THE CUTS WERE PERFORMED THE NOTCH GUIDE WAS APPLIED AND PERFORMED WITH A RECIP SAW. THE FEMORAL COMPONENT WAS THEN TRIALED AND A FRACTURE OF LATERAL CONDYLE WAS OBSERVED. THIS WAS FIXED WITH SCREWS AND PROLONGED SURGICAL TIME. THIS CAUSED PATIENT HARM. THE PATIENT CONSEQUENCE IS LONGER NO WEIGHT BARING REHAB.

  Patient problems: Bone Fracture(s)

  MAUDE report 21468067 ↗
• MalfunctionSep 9, 2024Unintended Movement; Unintended Movement

  THIS COMPLAINT WAS CREATED TO REPORT AVOIDING SAW BLADE DEFLECTION.

  Patient problems: Insufficient Information

  MAUDE report 20168021 ↗
• InjuryMar 15, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE SAW BLADE DETACHED FROM SAW HAND PIECE WHILE CUTTING FEMUR, SAW BLADE STAYED EMBEDDED IN THE FEMUR. BLACK LIQUID WAS NOTED AROUND WHERE THE SAW BLADE ATTACHES TO THE SAW HAND PIECE. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5.

  Patient problems: Foreign Body In Patient

  MAUDE report 18912725 ↗
• InjuryFeb 22, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT WHEN VERIFYING THE CUTS ON THE FEMUR, IT APPEARED THAT THE LATERAL POSTERIOR CUT HAD BEEN OVER RESECTED BY 1MM WHEN USING VELYS. WHEN SURGEON PUT TRIALS ON, HE NOTICED CONSIDERABLE 1-2MM GAPS BETWEEN BONE AND TRIAL FEMUR FOR THE: POSTERIOR, ANTERIOR, ANTERIOR CHAMFER AND DISTAL. LEFT TKR USING VELYS ATTUNE PS FB CONSTRUCT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18759467 ↗
• MalfunctionOct 6, 2023Failure to Cut; Failure to Cut

  THE BLADES ARE OF VERY POOR QUALITY. SURGEON WAS NOT ABLE TO USE IT EVEN FOR A BILATERAL KNEE. IT GETS VERY BLUNT AND IT IS CAUSING A LOT OF HEAT AND BURNING OF THE BONE. IT IS SURELY NOT WORTH THE PRICE NOR IS IT IDEAL TO BE USED WITH THE ROBOTIC ARM. IT IS SUPPOSED TO MAKE THE SURGEON'S EXPERIENCE EASIER AND BETTER AND NOT DIFFICULT AND TROUBLESOME WAS SURGERY DELAYED DUE TO THE REPORTED EVENT?: YES, IF YES, NUMBER OF MINUTES: 30 MINUTES, ACTION TAKEN WHEN EVENT OCCURRED?: USED ANOTHER NEW BLADE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887512 ↗
• MalfunctionApr 25, 2023Unintended Movement; Unintended Movement

  RIGHT VELYS TKR CASE, AFTER THE COMPLETION OF THE POSTERIOR CUT, WHEN VERIFYING THE LATERAL POSTERIOR CUT IT SHOWED THAT THE CUT WAS 4.5MM ANTERIOR, AS A RESULT WE HAD TO USE MORE CEMENT WHEN IMPLANTING DEFINITIVE PROSTHESIS. ALL OTHER CUTS WERE FINE AND FEMORAL ARRAY HAD NOT MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806100 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON STARTED VELYS RAS ATTUNE PS PRIMARY KNEE AFTER COMPLETION OF ALL INITIALIZATION, CALIBRATION AND DRAPING AS PER THE IFU. NATURAL JOINT ASSESSMENT AND PLANNING WAS THEN COMPLETED AND THE SURGEON CHOSE TO PERFORM A 2 DEGREE VARUS CUT ON THE TIBIA. THE KNEE WAS POSITIONED WITH 'Z' RETRACTORS PLACED MEDIAL AND LATERAL TO PROTECT THE COLLATERAL LIGAMENTS. AFTER FINISHING THE CUT WITH AN OSTEOTOME THE SENSOR TENSOR WAS THEN USED TO CHECK BALANCE WITH THE ACCUBALANCE GRAPH. IT WAS THEN NOTED AN UNEXPECTED INCREASE IN MEDIAL LAXITY RELATIVE TO THE LATERAL COMPARTMENT. AFTER FURTHER ASSESSMENT IT WAS IDENTIFIED THAT THE MCL WAS DAMAGED AND NEED REPAIR WITH FIBREWIRE. THIS WAS COMPLETED AND THE FEMORAL CUTS WERE COMPLETED WITH NAVIGATION. THE REST OF THE CASE PROCEEDED WITHOUT FURTHER DELAY OR INCIDENT. DOE: (B)(6) 2022.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14186364 ↗
• MalfunctionMar 14, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  PROBLEM REPORTED: SAW WAS REPORTED TO STUTTER DURING RESECTIONS. SURGEON UNABLE TO MAKE CUTS WITH SAW. SURGEON USED A MANUAL SAW TO COMPLETE THE SURGERY. DISTAL CUT WAS CONSIDERED UNBEARABLE. WHEN WAS THE ISSUE OBSERVED: DURING SURGERY TROUBLESHOOTING: SURGEON ATTEMPTED TO START SAW OF OFF THE BONE PRIOR TO MAKING CUT WITH NO SUCCESS. SAW CONTINUES TO STUTTER WHILE TRYING TO MAKE THE CUTS. FSE DISPATCHED WITH PARTS. 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: (B)(6) 2022. ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757535 ↗