ATTUNE 2545-00-045Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 10603295130529), received between Jul 31, 2017 and Sep 15, 2026 — classified as 1 injury, 221 malfunctions.

The most frequently reported specific device problem is “Break” (172 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778720 ↗
• MalfunctionSep 14, 2026No Apparent Adverse Event

  It was reported that the Attune posterior saw capture Sz 3-5-(lot PG235067) had plastic locking tab broken off. Detected post implant, outside of cases. There was no patient or user harm and no significant delay.Manufacturer received second Attune posterior saw capture Sz 3-5-(lot PG244054) with no device allegation. However during manufacturer's investigation of the received device it was identified that that the lever of the device was broken.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754517 ↗
• MalfunctionMay 13, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). DURING THE PROCEDURE, THE CAPTURE HAD THE PLASTIC CLIP BROKEN OFF AND WOULD NOT ATTACH TO THE BLOCK. THERE WERE NO DELAYS AND NOTHING WAS LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163475 ↗
• MalfunctionMay 8, 2026Break

  IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY (TKA). THE RED CLIP WAS BROKEN WHICH PREVENTED IT FROM LOCKING INTO A BLOCK. THERE WAS NOTHING LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126778 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE SAW CAPTURE PLASTIC TAB BROKE INTRAOP. NO FRAGMENTS WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021900 ↗
• InjuryApr 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A TOTAL SHOULDER DONE IN (B)(6) 2025, HAD SEVERAL DISLOCATIONS. DR WENT IN AND MADE A THICKER CONSTRUCT. DOI: (B)(6) 2025. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT SHOULDER.

  Patient problems: Joint Dislocation

  MAUDE report 24861987 ↗
• MalfunctionApr 7, 2026Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. THE PART OF THE RED BUTTON THAT CLICKS INTO THE 4 IN 1 BLOCK BROKE WHEN DISCONNECTING AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807472 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT PIECE BROKE DURING SURGERY, ALL PIECE'S RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790738 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENTS HAVE BEEN BROKEN OVER TIME. THEY WERE NOT USED, THERE WAS NO DELAY TO SURGERY, AND THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780648 ↗
• MalfunctionApr 3, 2026Material Deformation

  IT WAS REPORTED THE SCRUB TEAM NOTED THAT THE DEVICES ARE BENT. NO ISSUES CAUSED TO THE PROCEDURE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779527 ↗
• MalfunctionApr 2, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING THE FEMORAL CUTS, IT WAS OBSERVED THAT THE FEMORAL CUTTING GUIDE COMPONENT DID NOT ANCHOR SECURELY DUE TO A FRACTURED AREA. THERE WAS NO ADVERSE EFFECTS ON THE PATIENT, NOR DID IT PROLONG THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769762 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT THE SAW CAPTURE BROKE. THE RED TAB BROKE OFF. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24768954 ↗
• MalfunctionMar 20, 2026Break

  IT WAS REPORTED THAT THE RED PUSH BUTTON BROKE ON THE 3-5 CAPTURE. CAPTURE WON'T STAY IN 4-IN-1 CUT BLOCK, JUST SLIDES OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24648169 ↗
• MalfunctionFeb 17, 2026Break

  BROKEN KNEE INSTRUMENTS PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367119 ↗
• MalfunctionFeb 13, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE RED CLIP ON THE TUNE SAW CAPTURE SIZE 3-5 WAS BROKEN AND WOULD NOT STAY ATTACHED. THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333628 ↗
• MalfunctionJan 24, 2026Scratched Material; Illegible Information

  IT WAS REPORTED THE LETTERS AND NUMBERS ON THE TRIALS WERE WORN OUT AND SCRATCHED UP MAKING THEM HARD TO READ.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173646 ↗
• MalfunctionJan 23, 2026Break

  IT WAS REPORTED THAT WHILE REMOVING THE SAW CAPTURE AFTER USE, THE RED BUTTON BROKE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167029 ↗
• MalfunctionJan 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO A RIGHT TOTAL KNEE ARTHROPLASTY (TKA) SURGICAL PROCEDURE, WHILE OPENING THE SURGICAL INSTRUMENTS, IT WAS OBSERVED THAT THE ROBOTIC ASSISTED SAW HANDPIECE DEVICE WAS LEAKING OIL OUT OF THE HEAD. THEREFORE, A SECOND ROBOTIC ASSISTED SAW HANDPIECE DEVICE WAS OPENED, AND THE SAW HAD THE SAME OIL ON ITS HEAD AREA. IT WAS DETERMINED BOTH SETS WERE CONTAMINATED AND UNUSABLE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE MANUAL SAW CAPTURE WOULD NOT STAY ON THE CUTTING BLOCK. IT WAS DETERMINED THAT THE LOCKING MECHANISM WAS BROKEN. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT, OR SURGICAL DELAY. 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 24011648 ↗
• MalfunctionDec 30, 2025Break; Break

  IT WAS REPORTED THAT THE RED CLIP ON THE SAW CAPTURE BROKE AND WOULD NOT REMAIN SECURED TO THE CUT BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926337 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT THE RED TAB ON THE SAW CAPTURE WAS BROKEN IN TWO PIECES. THIS DID NOT HAPPEN IN SURGERY AND BOTH PIECES WERE FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888837 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THAT AS THE DOCTOR WAS CUTTING THE 4-1 FEMORAL BLOCK, THE SAW CAPTURE BROKE AND CAME OFF THE BLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732779 ↗
• MalfunctionNov 17, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CAPTURE DEVICE SPRING DID NOT ENGAGE PROPERLY WITH CUTTING BLOCKS. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569483 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT THE RED CLIP ON THE ATTUNE SZ 3-5 POSTERIOR SAW CAPTURE WAS DEPRESSED TO ALLOW CONNECTION TO FOUR IN 1 BLOCK AND BROKE OFF AFTER NORMAL USE. THE PROCEDURE BEING PERFORMED WAS ARTHROPLASTY. THERE WAS NO PATIENT INVOLVEMENT. ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526303 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE CAPTURE DEVICE SPRING IS LOOSE AND DOESN'T ENGAGE INTO CUTTING BLOCKS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491558 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement

  IT WAS REPORTED THAT THE CAPTURE DEVICE SPRING IS LOOSE AND DOESN'T ENGAGE INTO CUTTING BLOCKS. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491547 ↗