VELYS 4515-70-107Recalls & reported problems

Summary

The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 10603295519379), received between Nov 12, 2021 and Sep 17, 2026 — classified as 144 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (108 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 144 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806272 ↗
• MalfunctionSep 17, 2026Device Slipped

  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 3 of 3 for (b)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802613 ↗
• MalfunctionSep 15, 2026Device Slipped

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50776349 ↗
• MalfunctionApr 3, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24779434 ↗
• MalfunctionApr 3, 2026Premature Separation

  IT WAS REPORTED THAT WHILE PREPARING FOR A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, THE OPERATING ROOM TEAM OBSERVED THAT THE ARRAY COULD BE EASILY PULLED OUT OF THE ROBOTIC-ASSISTED SOLUTION ARRAY CLAMP DEVICE. THE DEVICE WAS BEING USED IN CONJUNCTION WITH THE ROBOTIC-ASSISTED SOLUTION ARRAY SET - KNEE DEVICE. THERE WAS FIVE-MINUTE DELAY TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. 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 24778482 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24769047 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768979 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768975 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768972 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768970 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768968 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768966 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768965 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768964 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768936 ↗
• MalfunctionApr 2, 2026Device Slipped

  IT WAS REPORTED THAT DURING DEVICE INSPECTION, IT WAS OBSERVED THAT (12) ARRAY CLAMP DEVICES WERE LOOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF SURGICAL 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 24768923 ↗
• MalfunctionApr 1, 2026Break; Material Fragmentation; Device-Device Incompatibility

  DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ROBOTIC-ASSISTED SOLUTION ARRAY CLAMP DEVICE WAS CHIPPED/SHAVED/DELAMINATED. IT WAS INITIALLY REPORTED THAT THE ARRAY CLAMP WAS NOT TIGHTENING PROPERLY, AND THE RUBBER WASHER OF THE CLAMP WAS DAMAGED. 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 24757205 ↗
• MalfunctionMar 30, 2026Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT 3X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24735324 ↗
• MalfunctionFeb 19, 2026Device Slipped; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24393412 ↗
• MalfunctionFeb 19, 2026Device Slipped; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393409 ↗
• MalfunctionFeb 18, 2026Device Slipped; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT 3X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24376689 ↗
• MalfunctionFeb 17, 2026Device Slipped; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363882 ↗
• MalfunctionFeb 17, 2026Device Slipped; Device-Device Incompatibility; Premature Separation

  IT WAS REPORTED THAT DURING SET-UP FOR A TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE COMING LOOSE ON THEIR OWN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. 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 24363880 ↗
• MalfunctionJan 14, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, WHILE USING SIX (X6) ROBOTIC ASSISTED ARRAY CLAMP DEVICES WITH TWO (X2) ROBOTIC ASSISTED SATELLITE STATION DEVICES, AND A ROBOTIC ASSISTED SAW HANDPIECE DEVICE, IT WAS OBSERVED THAT THE CONNECTION WAS LOOSE CAUSING SAW CUTOUTS. IT WAS ALSO REPORTED THAT THE ARRAYS WERE POPPING OUT OF THE CLAMPS. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS 6 OF 6 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066116 ↗
• MalfunctionJan 14, 2026Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, WHILE USING SIX (X6) ROBOTIC ASSISTED ARRAY CLAMP DEVICES WITH TWO (X2) ROBOTIC ASSISTED SATELLITE STATION DEVICES, AND A ROBOTIC ASSISTED SAW HANDPIECE DEVICE, IT WAS OBSERVED THAT THE CONNECTION WAS LOOSE CAUSING SAW CUTOUTS. IT WAS ALSO REPORTED THAT THE ARRAYS WERE POPPING OUT OF THE CLAMPS. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. THIS IS 5 OF 6 FOR THE SAME EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066104 ↗