ATTUNE 2544-00-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 10603295129752), received between Aug 3, 2017 and Aug 11, 2026 — classified as 88 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Structural Problem; Detachment of Device or Device Component

  It was reported that the up rod for the tibial cutting jig lost its spring and could not lock in the slope.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214398 ↗
• 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 25242123 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT ACTUATOR AND SPRING BROKEN PRIOR TO USE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163749 ↗
• MalfunctionMar 6, 2026Mechanical Jam

  IT WAS REPORTED THAT THE ANKLE CLAMP IS JAMMED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536589 ↗
• 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 24536565 ↗
• 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 24519608 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT THE TIBIAL JIG WAS BROKEN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401999 ↗
• MalfunctionFeb 4, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT INSTRUMENT SPRING MISSING ON UPROD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258602 ↗
• MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL JIG AND TIBIAL DISTAL UPROD WERE BECOMING STUCK TOGETHER; LUBRICATION WAS ATTEMPTED BUT DID NOT WORK. THE TIBIAL PROXIMAL UPROD WOULD NOT TIGHTEN, AND THE WHITE NUMBERING HAD FADED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827467 ↗
• MalfunctionDec 15, 2025Break; Break

  IT WAS REPORTED THAT DURING SET UP, PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THE INSTRUMENTS WERE BROKEN. IT WAS THE FIRST USE OF THE SET. ANOTHER SET WAS USED TO CONTINUE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO DELAY TO SURGERY OR PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810308 ↗
• MalfunctionNov 25, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE TIBIA CUTTING GUIDE UPROD KNOB BECAME FULLY UNTHREADED AND WOULD NOT FULLY ENGAGE INTO CLAMP HOLDER. IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. NO FURTHER INFO AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646788 ↗
• MalfunctionNov 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  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 23521258 ↗
• MalfunctionNov 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE TIBIAL JIG AND THE DISTAL UPROD GOT STUCK TOGETHER. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469662 ↗
• MalfunctionSep 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE UP ROD WAS NOT LOCKING INTO ANKLE CLAMP ON ATTUNE EM TIBIAL JIG, REPLACEMENT REQUIRED. NO IMPACT TO PATIENT, NO DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086449 ↗
• MalfunctionSep 4, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE DOCTOR COMPLAINED THAT THE TIBIA RESECTION GUIDES HAVE STARTED TO WARP AND ALL NUMBERS ARE WORN OFF. ALSO, THE SIZING GUIDE HAS ALL THE NUMBERS WORN OFF AND THE TIBIA ALIGNMENT HANDLE HAS THE RED PUSH PIECE BROKEN OFF. EVENT DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963542 ↗
• 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 22519534 ↗
• MalfunctionJul 8, 2025Mechanical Jam; Mechanical Jam

  IT HAS BEEN REPORTED DURING THE SURGICAL PREPARATION, IT WAS DISCOVERED THAT THE ALIGNMENT ROD WAS JAMMED. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436378 ↗
• MalfunctionJul 2, 2025Device-Device Incompatibility; Mechanical Jam; Scratched Material; Device-Device Incompatibility; Mechanical Jam; Scratched Material

  THE UP ROD WOULD NOT SLIDE ONTO THE ANKLE CLAMP CORRECTLY. IT SCRATCHED THE METAL AND FELT VERY TIGHT, GETTING STUCK AT THE VERY DISTAL END OF THE ANKLE CLAMP. SCRATCHES APPEARED ON THE INNER METAL WORK OF THE UP ROD. THERE WAS A FIVE MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386405 ↗
• MalfunctionMar 13, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE ATTUNE ANKLE CLAMP IS VERY STIFF AND OFTEN GETS STUCK, THUS MAKING IT UNUSABLE FOR SURGERY. THERE WAS NO EFFECT TO PATIENT AND NO SEVERE DELAY TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593245 ↗
• MalfunctionFeb 25, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE 2 TOOLS DON'T FIT TOGETHER. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462557 ↗
• MalfunctionDec 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICES WERE BEING TESTED IN CSSD PRIOR TO A PROCEDURE. THE ROD COULD NOT BE MOVED OVER THE MALLEOLUS FORK. NO SURGICAL DELAY. NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926667 ↗
• MalfunctionDec 5, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : THE PROBLEM WAS THAT THE 2 PARTS WERE NOT INTERACTING AS THEY SHOULD AND VERY STIFF TO MOVE BACKWARDS AND FORWARDS TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856820 ↗
• MalfunctionDec 2, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED AND STATES THAT : PLEASE CONFIRM IF THIS OCCURRED PRE/INTRA OR POST OP-OP? PRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819105 ↗
• MalfunctionOct 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 14, 2024, DURING THE SURGERY IT WAS NOT POSSIBLE TO MOUNT THE ATTUNE ANKLE CLAMP ONTO THE DISTAL ROD. THERE WAS NO SURGICAL DELAY AS THE ISSUE WAS DISCOVERED BEFORE SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514016 ↗
• MalfunctionSep 19, 2024Break; Crack; Break; Crack

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE DEVICE WAS CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261669 ↗