NA 1299-01-080Recalls & reported problems
Depuy (Ireland) · CAS LIGAMENT TENSOR SIZE 2-XF · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295027072), received between Apr 19, 2022 and Mar 18, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (8 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation8
- Mechanical Jam4
- Mechanical Problem3
- Scratched Material3
- Break2
- Naturally Worn2
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 24625541 ↗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 24131956 ↗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 24131717 ↗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 24131617 ↗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 24131551 ↗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 24131007 ↗MalfunctionFeb 21, 2025Scratched Material; Illegible Information; Scratched Material; Illegible Information
ADDITIONAL INFORMATION RECEIVED STATES THAT THE LOT NUMBER FOR THIS INSTRUMENT IS NOT LEGIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21435681 ↗MalfunctionDec 9, 2024Material Deformation; Material Deformation
IT WAS REPORTED, THAT THERE WAS A SHARP EDGE ON THE LIGAMENT TENSOR. THE INSTRUMENT WAS INSPECTED OUTSIDE OF THE THEATRE. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879399 ↗MalfunctionJul 11, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE SENSORS HAVE BECOME ROUGHENED AND SHARP AND NEED REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720688 ↗MalfunctionJul 11, 2024Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE SENSORS HAVE BECOME ROUGHENED AND SHARP AND NEED REPLACING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19720654 ↗MalfunctionJun 18, 2024Break; Break
IT WAS REPORTED THAT THE SENSOR TENSOR IS DAMAGED. THE DAMAGE WAS DISCOVERED PRE OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19556030 ↗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 19221013 ↗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 19220157 ↗MalfunctionJan 22, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
ADDITIONAL INFORMATION RECEIVED: WHERE WAS THE PRESENTATION TAKING PLACE? WAS THIS IN A SURGERY? -> NOT IN A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18553940 ↗MalfunctionSep 13, 2023Contamination /Decontamination Problem; Material Deformation; Contamination /Decontamination Problem; Material Deformation
CONTAMINATED SENSOR TENSOR FROM VELYS TRAY UNABLE TO CLEAN DUE TO SPRING BEING DISTORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17737896 ↗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 17306606 ↗MalfunctionApr 19, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE VELYS DEPARTMENT RECEIVED A CALL STATING THAT THE TENSOR HAD AN ISSUE AND THAT IT WAS NOT CLOSING PROPERLY DURING AN INSTALLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14141089 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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