NA 1299-01-081Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295027089), received between Mar 19, 2018 and Sep 29, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  It was reported that there was a broken VRAS instrument, no additional information was available. It was reported that the damage was not noticed by any of the theatre staff, meaning there was no impact on the surgery or the patient. The damage was only picked up by the SSD department following the conclusion of the operation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933226 ↗
• MalfunctionMar 18, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE, IT WAS OBSERVED THAT TWO ROBOTIC ASSISTED ARRAY CLAMP DEVICES WERE LOOSE. IT WAS FURTHER REPORTED THAT THE CAS LIGAMENT TENSOR SIZE 2-XF AND CAS LIGAMENT TENSOR SIZE 4-XF DEVICES WERE NOT WORKING. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL. 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 24631297 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED THE SURGEON STATES THAT THE TENSIONER SPRINGS ARE LOOSE DUE TO AGING AND PROLONGED USE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131912 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED THE SURGEON STATES THAT THE TENSIONER SPRINGS ARE LOOSE DUE TO AGING AND PROLONGED USE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131854 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED THE SURGEON STATES THAT THE TENSIONER SPRINGS ARE LOOSE DUE TO AGING AND PROLONGED USE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131365 ↗
• MalfunctionJan 21, 2026Material Deformation

  IT WAS REPORTED THE SURGEON STATES THAT THE TENSIONER SPRINGS ARE LOOSE DUE TO AGING AND PROLONGED USE. NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131237 ↗
• MalfunctionJul 11, 2024Scratched Material; Scratched Material

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO ADVERSE OUTCOMES OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19720735 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Jam; Mechanical Problem; Mechanical Jam

  PROBLEM REPORTED: MULTIPLE ISSUES: 451570107: THE TEETH HAVE BECOME DULL 129901080 AND 129901081: LOST TENSION 451570109: BUTTON TO SECURE ARRAY HAS COME LOOSE ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221019 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Jam; Unintended Movement; Mechanical Problem; Mechanical Jam; Unintended Movement

  PROBLEM REPORTED: MULTIPLE ISSUES: 451570107: THE TEETH HAVE BECOME DULL 129901080 AND 129901081: LOST TENSION 451570109: BUTTON TO SECURE ARRAY HAS COME LOOSE ALL INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220151 ↗
• MalfunctionJul 12, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE USING THE TOOLS FOR THE FIRST TIME FOR TRAINING, THAT THEY DO NOT MOVE SMOOTHLY AND EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17306607 ↗
• MalfunctionDec 16, 2021Material Deformation; Material Deformation

  TWO EACH SIZE 4 LIGAMENT TENSORS WERE FOUND DEFECTIVE UPON RECEIPT. THE SPRINGS ARE BENT AND CATCHING ON THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020402 ↗
• MalfunctionDec 16, 2021Material Deformation; Material Deformation

  TWO EACH SIZE 4 LIGAMENT TENSORS WERE FOUND DEFECTIVE UPON RECEIPT. THE SPRINGS ARE BENT AND CATCHING ON THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019438 ↗
• MalfunctionSep 9, 2021Incorrect Measurement; Mechanical Jam; Incorrect Measurement; Mechanical Jam

  IT WAS REPORTED THAT ONE SIDE OF THE SENSOR TENSOR JIG IS GROSSLY HARDER TO PUSH DOWN THAN THE OTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445720 ↗
• MalfunctionOct 5, 2018Material Deformation; Material Deformation

  IT WAS NOTED THAT THE INSTRUMENT DOES NOT FULLY COMPRESS AND SPRING BECOMES CAUGHT BETWEEN THE UPPER AND LOWER PLATES UPON COMPRESSION. THIS CAUSES ONE SIDE OF THE UPPER PLATE TO SIT HIGHER THAN THE OTHER UNTIL ENOUGH FORCE IS APPLIED TO 'CLICK' THE SPRING DOWN. ON VISUAL INSPECTION, THE SPRINGS APPEAR TO BE WARPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7937943 ↗
• MalfunctionMar 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  HOLDING UP ON THE SPRING WHEN BEING COMPRESSED. RIGHT SIDE (STICKY): 8.45 MM BEFORE ¿CLICK DOWN¿, 7.46 MM AFTER ¿CLICK DOWN¿, LEFT SIDE: 8.11 MM BEFORE ¿CLICK DOWN¿, 9.25 MM AFTER ¿CLICK DOWN¿ (TOP PLATE TILTS WHEN OPPOSITE SIDE IS COMPRESSED).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7348153 ↗