VELYS 4515-70-106Recalls & reported problems

Summary

The FDA's MAUDE database contains 564 adverse event reports that list this exact device (DI 10603295519478), received between Dec 20, 2021 and Sep 28, 2026 — classified as 564 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (500 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 564 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Slipped

  It was reported that during sterile processing it was observed that 2x Robotic Assisted Saw Interface Device (SASI) Right devices were loose. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.This is report 2 of 2 for(b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913752 ↗
• MalfunctionSep 28, 2026Device Slipped

  It was reported that during sterile processing it was observed that 2x Robotic Assisted Saw Interface Device (SASI) Right devices were loose. This event did not occur during a surgical procedure. There were no reports of injuries, medical intervention, or prolonged hospitalization. All available information has been disclosed. No further information was provided.This is report 1 of 2 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913751 ↗
• MalfunctionSep 23, 2026Device Slipped

  It was reported that during setup and registration of the Robotic Assisted Saw Interface Device (SASI) Right device for a Total Knee Arthroplasty (TKA) surgical procedure it was reported that the SASI was loose and received an Error on the Robotic Assisted Base Station Device: unable to connect to the Robotic Assisted Saw Handpiece Device. It was further observed that the SASI wash caps were worn and did not properly fit on the SASI while washing. It was reported that a different SASI was used to resolve the connection issue. It was not reported if the robot was mounted to the surgical bed. It was reported that there was a 10-minute delay in the procedure due to the event. 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 50867156 ↗
• MalfunctionSep 15, 2026Device Slipped

  It was reported that during a check it was noted that the VELYS SAW INTERFACE RIGHT was loose. The device was in use with the VELYS SAW HANDPIECE device and VELYS BASE STATION. The event did not occur during 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 50772849 ↗
• MalfunctionSep 11, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739994 ↗
• MalfunctionSep 8, 2026Device Slipped

  It was reported that during a Total Knee Arthroplasty (TKA) surgical procedure 6X Robotic Assisted Saw Interface Device (SASI) devices were loose and resulted in the saw cutting out. It was reported that the event involved 3 Right SASI devices and 3 Left SASI devices. It was reported that the events occurred throughout the procedure. It was not reported if 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. If additional information should become available, a Supplemental MedWatch will be submitted accordingly.This is report 3 of 6 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50667899 ↗
• MalfunctionAug 3, 2026Mechanical Problem; Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122439 ↗
• MalfunctionAug 3, 2026Mechanical Problem; Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50122337 ↗
• MalfunctionJul 27, 2026Device Slipped; Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50008062 ↗
• 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 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184000 ↗
• MalfunctionMay 11, 2026Device Slipped

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, WHEN USING THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT WITH THE ROBOTIC ASSISTED BASE STATION DEVICE IT WAS NOTED THE SAW INTERFACE PORTION THAT CLAMPS WITH THE VELYS SAW HANDPIECE WAS LOOSE DESPITE BEING FULLY CLOSED. IT WAS REPORTED THAT THIS MAY HAVE CONTRIBUTED TO ERROR MESSAGES DURING THE VELYS RESECTIONS. IT WAS REPORTED THAT THE ROBOT WAS MOUNTED TO THE SURGICAL BED. IT WAS REPORTED THAT THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143150 ↗
• MalfunctionMay 4, 2026Device Slipped

  THIS IS REPORT 2 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 25068513 ↗
• MalfunctionApr 15, 2026Device Slipped; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT AN ERROR MESSAGE POPPED UP ON THE VELYS UNIT. IT WAS REPORTED THAT HANDPIECE AND VELYS SAW INTERFACE RIGHT (SASI) WERE SWITCHED OUT AND THE CASE CONTINUED. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THERE WAS UNDESIRED MOVEMENT OR PLAY BETWEEN THE SASI CLAMP AND SASI ITSELF. 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 24889076 ↗
• 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 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851402 ↗
• MalfunctionApr 1, 2026Device Slipped

  IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT DEVICE WAS LOOSE. IT WAS REPORTED THAT WHEN THE SAW WAS ATTACHED, IT HAD TOO MUCH MOVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755684 ↗
• MalfunctionApr 1, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, WHILE USING THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT WITH THE ROBOTIC ASSISTED BASE STATION DEVICE, IT WAS OBSERVED THAT THE SASI WOULD NOT HOLD THE SAW TIGHT. THE EVENT OCCURRED WHILE DEICE WAS BEING USED FOR THE CHAMFER CUT, THE CHAMFER CUT WAS MANUAL. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755610 ↗
• MalfunctionMar 30, 2026Device Slipped

  THIS IS EVENT 2 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 24727492 ↗
• MalfunctionMar 30, 2026Device Slipped; Device-Device Incompatibility

  THIS IS REPORT 2 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 24717564 ↗
• MalfunctionMar 23, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING PRE-SURGERY SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, IT WAS OBSERVED THAT THE PLASTIC PLUG ON THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) DEVICE WAS BROKEN. 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 24662514 ↗
• MalfunctionMar 19, 2026Mechanical Problem; Device Slipped

  IT WAS REPORTED THAT DURING DISTAL CUTS ON A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE BOTTOM LATCH ON THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (RIGHT) CAME LOOSE WHILE BRINGING THE SAW INTO THE DISTAL PLANE. THE SAW STOPPED BRIEFLY AND THEN RESUMED. A CLEANING CAP WAS NEEDED. THE SURGEON HELD THE CLASP CLOSED WITH A FINGER. THERE WAS A CUT IN THE INSULATION OF THE SAW CABLE ON THE ROBOT; IT WAS TAPED. 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 24637467 ↗
• MalfunctionMar 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE VELYS SAW INTERFACE RIGHT DEVICE WAS LOOSE. IT WAS REPORTED IN THE SERVICE ORDER THAT DURING INSPECTION OF THE CLEANING CUPS, IT WAS NOTED THAT THE DEVICE O-RINGS HAD DEGRADED AND WERE STARTING TO FLAKE. 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 24537651 ↗
• MalfunctionMar 2, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SAW CLAMP ON THE VELYS SAW INTERFACE RIGHT DEVICE WAS TOO LOOSE WHICH RESULTED IN INSUFFICIENTLY FIRM SEATING OF THE "HP". 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 24489028 ↗
• MalfunctionMar 2, 2026Device Slipped; Premature Separation

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE WAS LOOSE AND THE LATCH CAME OPEN DURING THE CASE. 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 24485008 ↗
• MalfunctionMar 2, 2026Device Slipped; Premature Separation

  IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) RIGHT WAS LOOSE AND THE LATCH CAME OPEN DURING THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24479811 ↗
• MalfunctionFeb 24, 2026Device Slipped

  IT WAS REPORTED THAT DURING A FIELD SERVICE ENGINEER VISIT IT WAS OBSERVED THAT THE LEFT AND RIGHT ROBOTIC ASSISTED SAW INTERFACE DEVICE (SASI) WERE FOUND TO BE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO REPORTS OF INJURIES. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434959 ↗