ATTUNE 2544-00-001Recalls & reported problems
Depuy (Ireland) · ATTUNE EXTRA-MEDULLARY TIBIAL ANKLE CLAMP · Class 1
All models of ATTUNE (1475)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Attune ankle clamp has 146 FDA adverse event reports, with no deaths and no injuries. All are logged as malfunctions, and many describe the clamp breaking, jamming or cracking. Some mention it being hard to adjust or not fitting other parts of the kit. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 144
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 10603295129738), received between Sep 26, 2017 and Jul 2, 2026 — classified as 144 malfunctions.
The most frequently reported specific device problem is “Break” (61 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
- Break61
- Device-Device Incompatibility33
- Mechanical Jam28
- Crack12
- Naturally Worn4
- Unintended Movement4
- Illegible Information3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions114
- No Consequences Or Impact To Patient15
- Insufficient Information14
- No Information2
- No Known Impact Or Consequence To Patient1
- Not Applicable1
Recent adverse event reports
The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2026Material Deformation
IT WAS REPORTED THAT DURING A SHOULDER REPAIR, BOTH DEVICES WERE STRIPPED AND NEED TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25689967 ↗MalfunctionMay 27, 2026Break
IT WAS REPORTED THAT THE ATTUNE TIBIAL JIG BROKE DURING INSERTION. IT WAS FURTHER REPORTED THAT THE DEVICE BROKE INTO TWO PIECES AND ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25302066 ↗MalfunctionMay 25, 2026Break
IT WAS REPORTED THAT TIBIAL GUIDE FELL OFF THE TABLE AND ANKLE CLAMP BROKE. NO DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270897 ↗MalfunctionMay 21, 2026Device-Device Incompatibility
EXTRAMEDULLARY ANKLE ATTACHMENT DOES NOT SLIDE WELL IN DISTAL TIBIAL SIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25242122 ↗MalfunctionMay 7, 2026Mechanical Jam
IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE ANKLE CLAMP WAS EXTREMELY TIGHT AND NEARLY IMPOSSIBLE TO ADJUST. IT WAS REPORTED THAT THE DEVICE HAD BEEN LUBRICATED BUT THE RATCHET SYSTEM WAS NO LONGER WORKING PROPERLY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. 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 25116166 ↗MalfunctionMay 7, 2026Mechanical Jam
THE SURGEON COULD NOT DIAL THE ANKLE CLAMP TO ALIGN IT WITH THE TIBIA. THERE WAS NO PATIENT HARM AND NO DELAYS TO THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112002 ↗MalfunctionApr 7, 2026Break
IT WAS REPORTED THAT ON UPON OFFICE IN HOUSE INSPECTION, IT WAS FOUND THAT THE INSTRUMENT WAS BROKEN. NO PREVIOUS CASES WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811635 ↗MalfunctionApr 1, 2026Mechanical Jam
IT WAS REPORTED THAT TIBIAL JIG V/V ADJUSTMENT IS STUCK. THE ISSUE REQUIRED THE USE OF ANOTHER TRAY AND SET. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24755667 ↗MalfunctionMar 25, 2026Break
IT WAS REPORTED THAT THE ANKLE CLAMP BROKE OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24690757 ↗MalfunctionMar 17, 2026No Apparent Adverse Event
INSTRUMENTS WERE REPORTED FOR UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617265 ↗MalfunctionMar 6, 2026Mechanical Jam
ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE CONFIRM THE QUANTITY OF PRODUCTS INVOLVED? IT WAS 2 PRODUCTS, THE ATTUNE EM TIBIAL DIST UPROD AND THE ATTUNE EM TIBIAL ANKLE CLAMP. THESE ITEMS WERE JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536529 ↗MalfunctionMar 6, 2026Mechanical Jam
ADDITIONAL INFORMATION RECEIVED: CAN YOU PLEASE CONFIRM THE QUANTITY OF PRODUCTS INVOLVED? IT WAS 2 PRODUCTS, THE ATTUNE EM TIBIAL DIST UPROD AND THE ATTUNE EM TIBIAL ANKLE CLAMP. THESE ITEMS WERE JAMMED TOGETHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24536520 ↗MalfunctionMar 5, 2026Device-Device Incompatibility
IT WAS REPORTED THAT THE ANKLE CLAMP IS BROKEN AND TWO PARTS WON'T SLIDE TOGETHER. THE SET WAS USED FOR DEMO. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519606 ↗MalfunctionFeb 18, 2026Device-Device Incompatibility
IT WAS REPORTED THAT ATTUNE TIBIAL JIG WAS NOT ENGAGING THE ANKLE CLAMP ANYMORE VIA THE RED ACTION BUTTON. IT WAS REPORTED THAT THE SPRING SEEMED TO HAVE GIVEN OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24384679 ↗MalfunctionJan 13, 2026Break
IT WAS REPORTED THAT THE ANKLE BRACE FOR THE ATTUNE KNEE BROKE IN HALF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24054165 ↗MalfunctionJan 12, 2026Mechanical Jam
IT WAS REPORTED THAT AFTER A TOTAL KNEE ARTHROSCOPY (TKA) SURGICAL PROCEDURE, DURING INSPECTION OF THE ATTUNE EM TIBIAL ANKLE CLAMP DEVICE IT WAS OBSERVED THAT PART OF THE DIAL WAS NOT WORKING PROPERLY. SPECIFICALLY, THE DIAL COULD NOT TURN SMOOTHLY BECAUSE THERE WAS A CATCH ON THE RED DIAL PART USED WHEN THE CHANGING INVERSION AND EVERSION. IT WAS REPORTED THAT WHEN THE DIAL WAS TURNED CLOCKWISE AND COUNTERCLOCKWISE SIMILARLY, THE DIAL FELT LIKE IT STOPPED PARTWAY DURING ROTATION. HOWEVER, IT COULD TURN WHEN IT WAS ATTEMPTED TO ROTATE MULTIPLE TIMES. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24031991 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY (TKA, IT WAS OBSERVED THAT THERE WAS A BROKEN ANKLE CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981519 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT WHEN PLACING THE ANKLE CLAMP ON THE PATIENT, THE BLACK PLASTIC MALLEOLUS CLAMP BROKE OFF. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850004 ↗MalfunctionDec 16, 2025Break; Break
IT WAS REPORTED THAT SURGEON PULLED OFF ANKLE CLAMP AND CLAMP SNAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821180 ↗MalfunctionDec 3, 2025Break; Break
IT WAS REPORTED THAT THE ELASTIC PART OF ANKLE CLAMP BROKE OFF. NO DELAY. NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704034 ↗MalfunctionNov 20, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT PRIOR TO SURGERY THE ANKLE CLAMP JAMMED AND THE INSERT HAD WEAR AND TEAR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23609961 ↗MalfunctionNov 11, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam
IT WAS REPORTED THAT FOR THE SECOND TIME THE TIBIAL JIG AND THE DISTAL UPROD GOT STUCK TOGETHER. (B)(4) WAS CREATED FOR 1ST TIME EVENT OCCURRENCE, (B)(4) WAS CREATED FOR 2ND TIME EVENT OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23521442 ↗MalfunctionNov 10, 2025Break; Break
IT WAS REPORTED THAT TIBIAL JIG WAS DROPPED IN SURGERY SET UP AND EXPLODED ON THE FLOOR. DISTAL CUT BLOCK CLAMP ATTACHMENT. RED TIP BROKE OFF IN SURGERY SET UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23513026 ↗MalfunctionJul 25, 2025Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE KNOBS THAT TURN THE CLAMP TO ALTER THE VARUS VALGUS HAVE STUCK AND WILL NOT ADJUST. THIS WAS NOTICED OUTSIDE OF SURGERY SO NO PATIENT WAS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610441 ↗MalfunctionJul 16, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT THE TIBIAL JIG AND TIBIAL DISTAL UPROD REPORTED FOR AN UNKNOWN REASON. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22519699 ↗
Other CLAMP devices
- NA 2178-63-134Depuy (Ireland) · CLAMP137 reports
- ATTUNE 2545-01-055Depuy (Ireland) · CLAMP128 reports
- SPECIALIST 86-5035Depuy (Ireland) · CLAMP101 reports
- SPECIALIST 96-6670Depuy Orthopaedics, Inc. · CLAMP92 reports
- ATRAUMATA FB469RAesculap AG · CLAMP1 recall0 reports
- Centurion I68080Centurion Medical Products Corporation · CLAMP1 recall0 reports
- ATRAUMATA FB459RAesculap AG · CLAMP1 recall0 reports
- Centurion A547STCenturion Medical Products Corporation · CLAMP1 recall0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page