ATTUNE 2545-00-156Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10603295395294), received between Apr 11, 2019 and Mar 13, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (18 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT THE ATTUNE A-P CHAMFER BLOCK SZ 6 WAS REPORTED WITH A SHARP CHIP. THE EVENT WAS IDENTIFIED DURING A LOAN KIT INSPECTION AND NO PATIENT OR PROCEDURAL DETAILS WERE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24598741 ↗
• MalfunctionFeb 20, 2026Failure to Cut

  IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399488 ↗
• MalfunctionFeb 20, 2026Failure to Cut

  IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) IS RELATED TO (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399462 ↗
• MalfunctionFeb 20, 2026Failure to Cut

  IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4) WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399460 ↗
• MalfunctionFeb 20, 2026Failure to Cut

  IT WAS REPORTED THAT THE CUT BLOCKS WERE 10+ YEARS OLD. THERE HAVE BEEN SEVERAL CASES WHERE THE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM. (B)(4). WHICH CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399454 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  IT WAS REPORTED THAT FACILITY'S CUT BLOCKS WERE 10+ YEARS OLD. NEED TO BE REPLACED AS THEY HAVE HAD 2+ CASES WHERE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368758 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  IT WAS REPORTED THAT FACILITY'S CUT BLOCKS WERE 10+ YEARS OLD. NEED TO BE REPLACED AS THEY HAVE HAD 2+ CASES WHERE CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368757 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366596 ↗
• MalfunctionFeb 17, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF. NEW CUT BLOCKS ELEVATE THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366595 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320521 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320445 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320442 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320439 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320438 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAD SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320437 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320382 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320380 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320379 ↗
• MalfunctionFeb 12, 2026Failure to Cut

  IT WAS REPORTED THAT THEIR CUT BLOCKS WERE 10+ YEARS OLD. NEED TO REPLACE THEM AS THEY HAVE HAD 2+ CASES THAT CUTS HAVE SEEMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24320378 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED SEVERAL INSTRUMENTS WERE BROKEN. THIS DID NOT HAPPEN DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349612 ↗
• MalfunctionOct 7, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE CUTTING BLOCK SIZE 6 ATTUNE CHIPPED. THERE WAS NO SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20382874 ↗
• MalfunctionJul 1, 2024Corroded; Corroded

  IT WAS REPORTED THAT THERE WAS RUST ON PART OF THE BLOCK. NO DELAYS. NOTHING LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645907 ↗
• MalfunctionApr 12, 2024Material Deformation; Material Deformation

  AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY. NO FURTHER INFORRMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096260 ↗
• MalfunctionApr 12, 2024Material Deformation; Material Deformation

  AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096110 ↗
• MalfunctionApr 12, 2024Material Deformation; Material Deformation

  AT A GENERAL CHECK OF THE ATTUNE AP CUTTING BLOCKS THE CENTRAL STERILIZATION DEPARTMENT DETECTED SUBSTANTIAL SHARP EDGES AT THE CORNERS OF THE CUTTING SLOTS. THERE WERE NO IMPLICATIONS DURING ANY SURGERY! NO FURTHER INFORRMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19096108 ↗