VELYS 4515-70-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 578 adverse event reports that list this exact device (DI 10603295519461), received between Dec 22, 2021 and Sep 10, 2026 — classified as 578 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (508 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 578 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Device Slipped

  It was reported that while setting up a Total Knee Arthroplasty (TKA) surgical procedure using a Robotic Assisted Saw Interface Device (SASI) Left, a Robotic Assisted Satellite Station Device, and a Robotic Assisted Base Station Device it was observed that the SASI had lots of micro motion when the saw was cradled. It was reported that the device was removed and not used. It was reported that the device was not 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 50714798 ↗
• MalfunctionAug 24, 2026Device Slipped; Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410434 ↗
• MalfunctionAug 3, 2026Mechanical Problem; Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122350 ↗
• MalfunctionMay 15, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, WHEN USING THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT DEVICE AND THE SASI LEFT DEVICE IT WAS OBSERVED THAT THE LOCKING MECHANISMS WERE LOOSE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS EVENT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184002 ↗
• MalfunctionMay 4, 2026Device Slipped

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) DEVICE WAS LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, AN INSPECTION OF THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (RIGHT) WAS PERFORMED, AND SIMILAR LOOSENESS WAS ALSO CONFIRMED. 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 25068517 ↗
• MalfunctionMay 4, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VELYS SAW INTERFACE LEFT DEVICE WAS WOBBLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068166 ↗
• MalfunctionMay 4, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY, IT WAS DISCOVERED THAT THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) DEVICE WAS WOBBLY. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS USED TO COMPLETE THE 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 25067939 ↗
• MalfunctionApr 24, 2026Device Slipped

  IT WAS REPORTED THAT THE VELYS SAW INTERFACE LEFT DEVICE WAS VERY LOOSE MAKING IT UNUSABLE. THE DEVICE WAS IN USE WITH THE VELYS BASE STATION DEVICE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. 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 24988604 ↗
• MalfunctionApr 20, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) DEVICE DID NOT HOLD THE SAW PROPERLY AND WAS GETTING LOOSE. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT. 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 24927473 ↗
• MalfunctionApr 15, 2026Device Slipped

  IT WAS REPORTED THAT DURING KNEE SURGERY THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) DEVICE CLAMP WAS LOOSE AND HAD TO BE TAPED DOWN TO COMPLETE THE SURGERY. 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 24887733 ↗
• MalfunctionApr 15, 2026Material Fragmentation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) LEFT HAD A BROKEN WELD AS ONE OF THE SAW HANDPIECE (SH) LEVER PINS WAS FOUND PROTRUDING FROM THE LEVER SURFACE. IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, WHILE ATTEMPTING TO MAKE CUTS USING THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE, WITH THE ROBOTIC ASSISTED BASE STATION DEVICE, THE ROBOTIC ASSISTED SATELLITE STATION DEVICE, AND THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) LEFT, ONCE ON PLANE, IT WAS OBSERVED THAT THE SAW HAND PIECE ENGAGED ITSELF WITHOUT PULLING THE TRIGGER. IT WAS REPORTED THAT THE SURGEON DOCKED THE DEVICE AND SWAPPED IT OUT WITH A DIFFERENT UNIT. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE SURGICAL BED. THERE WERE NO 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 24885768 ↗
• MalfunctionApr 11, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, DURING TESTING, IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) LEFT AND A ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT HAD A LOT OF GIVE AND WERE NOT TIGHT TO THE TO THE VELYS BASE STATION AND VELYS SATELLITE STATION. IT WAS REPORTED THAT THIS HAS CAUSED CUT ISSUES. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE BED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849920 ↗
• MalfunctionApr 11, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, DURING TESTING, IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) LEFT AND A ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT HAD A LOT OF GIVE AND WERE NOT TIGHT TO THE TO THE VELYS BASE STATION AND VELYS SATELLITE STATION. IT WAS REPORTED THAT THIS HAS CAUSED CUT ISSUES. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE BED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24848063 ↗
• MalfunctionApr 6, 2026Device Slipped

  IT WAS REPORTED THAT WHEN THE USER LOCKED THE SAW INTO THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) DEVICE, THERE WAS SIGNIFICANT TOGGLE AND PLAY IN THE SAW. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. 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 24793020 ↗
• MalfunctionMar 31, 2026Break; Mechanical Jam

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT SAW LEVER ON THE ROBOTIC ASSISTED SAW INTERFACE (SASI) DEVICE WAS FRACTURED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS FROZEN DURING SET-UP. A SPARE DEVICE WAS AVAILABLE FOR USE. 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 24746376 ↗
• MalfunctionMar 30, 2026Device Slipped

  THIS IS EVENT 1 OF 2 OF (B)(4). IT WAS REPORTED THAT DURING A KNEE SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VELYS SAW INTERFACE LEFT DEVICE AND VELYS SAW INTERFACE RIGHT DEVICES WERE LOOSE IN THE SADDLE WHILE IN USE WITH THE VELYS BASE STATION AND THE VELYS SATELLITE STATION DEVICE. THE SYSTEM CLAIMED MISALIGNMENT. THE BLUE DOT WOULD RUN OUTSIDE TOLERANCE AND WOULD NOT ALLOW PROCEEDING. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727447 ↗
• MalfunctionMar 30, 2026Device Slipped; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGERY, THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE DEVICES WERE CUTTING IN AND OUT THROUGHOUT SURGERY. THE ROBOT WAS NOT MOUNTED TO THE BED. THE DEVICES WERE OPERATED IN CONJUNCTION WITH THE ROBOTIC-ASSISTED SOLUTION BASE STATION DEVICE AND THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE. IT WAS REPORTED THAT THERE WAS PATIENT INVOLVEMENT. 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 24717516 ↗
• MalfunctionMar 13, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VELYS SAW INTERFACE LEFT DEVICE WAS LOOSE. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE WOULD NOT LOCK, IT POPPED OPEN WHEN ATTACHED AFTER A SURGICAL PROCEDURE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A 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 24595454 ↗
• MalfunctionMar 11, 2026Device Slipped

  IT WAS REPORTED THAT PRIOR TO THE START OF A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, DURING CALIBRATION, THE ROBOTIC ASSISTED SAW INTERFACE (SASI) DEVICE WAS LOOSE. A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO DELAY IN THE SURGERY. 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 24571506 ↗
• MalfunctionMar 6, 2026Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING EVALUATION OF THE ROBOTIC ASSISTED SAW INTERFACE DEVICE, IT WAS FOUND THAT THE DEVICE WAS LOOSE. IT WAS INITIALLY REPORTED THAT THE THE ANTERIOR CHAMFER CUT WAS OFF IT WAS THOUGHT THAT AN ARRAY MIGHT HAVE MOVED. IN THE 3RD CASE, THE SAW WAS NOT FIRING FULLY, LIKE IT WASN'T GETTING POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 24535045 ↗
• MalfunctionMar 6, 2026Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING EVALUATION OF THE ROBOTIC ASSISTED SAW INTERFACE DEVICE, IT WAS FOUND THAT THE DEVICE WAS LOOSE. IT WAS INITIALLY REPORTED THAT THE ANTERIOR CHAMFER CUT WAS OFF IT WAS THOUGHT THAT AN ARRAY MIGHT HAVE MOVED. IN THE 3RD CASE, THE SAW WAS NOT FIRING FULLY, LIKE IT WASN'T GETTING POWER. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 24534960 ↗
• MalfunctionMar 5, 2026Device Slipped; Blocked Connection

  IT WAS REPORTED THAT DURING THE REGISTRATION STAGE OF A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE SPRINGS ON THE ROBOTIC ASSISTED SAW INTERFACE (SASI) WERE VERY LOOSE AND THE SAW HANDPIECE DEVICE WOULD NOT REGISTER. THE DEVICES WERE SWAPPED OUT AND THE PROCEDURE WAS COMPLETED. THERE WAS AN UNSPECIFIED AMOUNT OF DELAY DUE TO THE EVENT. 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 24520738 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE WAS LOOSE. IT WAS INITIALLY REPORTED THAT THE ANTERIOR CHAMFER, ANTERIOR AND TIBIA FOR SURGEON WAS 1-2 MM OVER RESECTION FOR EACH CUT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 24489646 ↗
• MalfunctionMar 2, 2026Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING EVALUATION OF THE DEVICE, IT WAS DETERMINED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE WAS LOOSE. IT WAS INITIALLY REPORTED THAT THE ANTERIOR CHAMFER, ANTERIOR AND TIBIA FOR SURGEON WAS 1-2MM OVER RESECTION FOR EACH CUT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 24489579 ↗
• MalfunctionFeb 26, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE WAS TOO LOOSE WHICH RESULTED IN INSUFFICIENTLY FIRM SEATING OF THE HANDPIECE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456976 ↗