VELYS 4515-70-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10603295519485), received between Nov 14, 2022 and Sep 23, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (21 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device Slipped; Device-Device Incompatibility

  It was reported that during a Total Knee Arthroplasty (TKA), the VELYS Array Interface device was not tightening in the middle and could be pulled out easily. There was no delay in the procedure reported. 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 50868048 ↗
• MalfunctionFeb 25, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WHILE USING THE ROBOTIC ASSISTED SAW INTERFACE DEVICE AND THE ARRAY INTERFACE DEVICE IT WAS OBSERVED THAT THE DEVICE ARRAY WAS LOOSE AND THE LEFT SAW INTERFACE WAS LOOSE AT THE SAW CONNECTION, CAUSING THE SAW TO CUT OUT A BIT. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24442515 ↗
• MalfunctionFeb 24, 2026Device Slipped

  IT WAS REPORTED THAT BEFORE AN UNSPECIFIED SURGERY, THE ARRAY INTERFACE LOCKING LEVER BECAME LOOSE WHEN CONNECTING TO THE ROBOT. FIXATION WAS UNAFFECTED AND THE SURGERY PROCEEDED WITHOUT DELAY. 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 24431485 ↗
• MalfunctionFeb 20, 2026Device Slipped; Device-Device Incompatibility

  THIS IS REPORT 1 OF 3 OF (B)(4). IT WAS REPORTED THAT DURING AN TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT WHILE USING THE VELYS DEVICE ARRAY INTERFACE DEVICE, VELYS DEVICE ARRAY INTERFACE DEVICE, VELYS SAW INTERFACE LEFT DEVICE, VELYS SATELLITE STATION DEVICE, VELYS SAW HANDPIECE DEVICE AND THE VELYS SAW INTERFACE RIGHT, THEY HAD TO BAIL TO MANUAL DUE TO THE DISTAL RESECTION TRYING CUT WAY MORE THAN PLANNED AND UNABLE TO CUT THE ANTERIOR CHAMFER. THE CUTS WERE OFF DISTALLY 1MM AND ANTERIORLY 1.5 MM AND WAS VERIFIED WITH THE POINTER. THE DEVICE ARRAY INTERFACE WAS FITTING VERY LOOSE ON THE ROBOT AND THE SASI WAS VERY LOOSE. THERE WAS SOME UNKNOWN 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 24405393 ↗
• MalfunctionFeb 20, 2026Device Slipped

  IT WAS REPORTED THAT POST PROCEDURE IT WAS OBSERVED THAT THE BOLT BEHIND WHERE THE ROBOTIC ASSISTED ARRAY DEVICE ATTACHES TO THE ROBOTIC ASSISTED SATELLITE STATION DEVICE WAS VERY LOOSE AND WOBBLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WERE NO 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 24403108 ↗
• MalfunctionFeb 17, 2026Device Slipped; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) SURGERY, THE ROBOTIC-ASSISTED SOLUTION DEVICE ARRAY INTERFACE FIT VERY LOOSE ON THE ROBOT AND THE ROBOTIC-ASSISTED SOLUTION SAW INTERFACE (LEFT) WAS ALSO VERY LOOSE. IT WAS FURTHER REPORTED THAT THERE WERE ISSUES WITH THE CUTS. THE DISTAL CUT WAS OFF BY 1 MM AND THE ANTERIOR CUT WAS OFF BY 1.5 MM, VERIFIED WITH THE POINTER. THE DEVICES WERE OPERATED IN CONJUNCTION WITH THE ROBOTIC-ASSISTED SOLUTION BASE STATION DEVICE AND THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE. THE PROCEDURE WAS DELAYED, THOUGH THE EXACT DURATION OF THE DELAY WAS NOT SPECIFIED. 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 24365169 ↗
• MalfunctionDec 4, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS WOBBLING AT THE ROBOT AND NEEDS TO BE REPLACED. IT WAS REPORTED THAT THIS OCCURRED DURING DEVICE SET UP. 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 23715221 ↗
• MalfunctionNov 17, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT POST PROCEDURE IT WAS OBSERVED THAT THE ROBOTIC ASSISTED ARRAY CLAMP DEVICE KEPT POPPING OFF. IT WAS REPORTED THAT THE ARRAY DEVICE KEPT DISENGAGING FROM THE MATING DEVICE. IT WAS REPORTED THAT THE WAS NO VISIBLE DAMAGE AND THE ROBOTIC ASSISTED SATELLITE STATION DEVICE WAS IN GREAT CONDITION. 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 23573383 ↗
• MalfunctionNov 6, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT AT THE END OF A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE VELYS DEVICE ARRAY INTERFACE DEVICE CORD HAD EXPOSED WIRES AND A BOLT WAS LOOSE ON THE DEVICE ARRAY. THE DEVICE WAS IN USE WITH VELYS SATELLITE STATION DEVICE AND THE VELYS BASE STATION DEVICE. 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 23486802 ↗
• MalfunctionSep 17, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING UNPACKING OF THE NEW VELYS TRAYS AND INSTRUMENTS, THE ROBOTIC-ASSISTED SOLUTION DEVICE ARRAY INTERFACE DEVICE IN ONE SET OF THE TRAYS WAS FOUND TO BE BROKEN. IT WAS ALSO REPORTED THAT THE CLEANING CAPS WERE MISSING. THE EVENT WAS NOT RELATED TO 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 23075836 ↗
• MalfunctionAug 13, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS TOO LOOSE, WOULD NOT HOLD ON PROPERLY. THERE WAS NO DELAY TO 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 22793233 ↗
• MalfunctionAug 12, 2025Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WOULD NOT STAY ON PROPERLY. THE CLAMP WAS TOO LOOSE. 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 22786727 ↗
• MalfunctionDec 27, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AT THE END OF A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE CLAMP BROKE. 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 21025485 ↗
• MalfunctionOct 24, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS LOOSE AND HAD TOO MUCH MOVEMENT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. 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 20522628 ↗
• MalfunctionJun 7, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE TWO (X2) ROBOTIC ASSISTED VELYS ARRAY CLAMP DEVICES WERE NOT HOLDING TIGHT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. 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. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492736 ↗
• MalfunctionJun 7, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE TWO (X2) ROBOTIC ASSISTED VELYS ARRAY CLAMP DEVICES WERE NOT HOLDING TIGHT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. 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. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489775 ↗
• MalfunctionMay 2, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS HAVING ISSUES HOLDING THE ARRAY. IT WAS REPORTED THAT THE BUTTON TO SECURE THE ARRAY BECAME LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228797 ↗
• MalfunctionMay 2, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE HAD COME LOOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228512 ↗
• MalfunctionJan 4, 2024Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING EQUIPMENT CHECKS, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICES RIGHT AND LEFT, THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE AND ARRAY INTERFACE DEVICE WERE HAVING ISSUES WITH LOOSE CLAMPS AND SAW HANDPIECE CONNECTIONS. IT WAS ALSO REPORTED THAT THERE WERE ISSUES WITH THE POWER CABLE PLUGGING IN. 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. THIS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18444397 ↗
• MalfunctionDec 20, 2023Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  IT WAS REPORTED THAT DURING PRIOR SURGERY IT WAS FOUND THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS TOO LOOSE AND MOVING A COUPLE OF INCHES. IT WAS FOUND THAT THE CLAMP WAS WORN OUT. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363374 ↗
• MalfunctionDec 8, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WOULD NOT LOCK AND COULD NOT BE CONNECTED. IT WAS REPORTED THAT THEY SECURELY FASTENED WITH OIF TAPE AND USED. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 18294475 ↗
• MalfunctionDec 8, 2023Device Slipped; Device Slipped

  IT WAS REPORTED THAT DURING PRE-SURGERY THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS LOOSE AND HAD A LOT OF PLAY WHEN CLAMPED DOWN. 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293495 ↗
• MalfunctionDec 21, 2022Device Slipped; Device Slipped

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE THE ROBOTIC ASSISTED SAW INTERFACE DEVICE WAS VERY LOOSE. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS ALSO LOOSE. IT WAS REPORTED THAT THERE WERE NO DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION REPORTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023302 ↗
• MalfunctionDec 15, 2022Mechanical Problem; Device Slipped; Mechanical Problem; Device Slipped

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS LOOSE AND POPPED OPEN AT THE SLIGHTEST TOUCH. IT WAS REPORTED THAT NO PIECES BROKE OFF. IT WAS ALSO REPORTED THAT THE ROBOTIC ASSISTED SAW INTERFACE DEVICE ONE RIGHT AND ONE LEFT CLAMPS WERE LOOSE. IT WAS NOT REPORTED WHEN THESE ISSUES WERE DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 15986125 ↗
• MalfunctionNov 14, 2022Mechanical Problem; Premature Separation; Mechanical Problem; Premature Separation

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED ARRAY INTERFACE DEVICE WAS NOT LOCKING PROPERLY AND KEPT POPPING OFF DURING SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. 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 15787447 ↗