ATTUNE 2544-00-026Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295395614), received between Nov 22, 2021 and Nov 19, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. FEMORAL FINISHERS SHOWED SIGN OF WEAR, WITH TORN UP EDGES FROM REPEATING CUTTINGS. NEEDED TO REPLACE THOSE THAT HAVE THE MOST WEAR. NO ISSUES TO PATIENT. NO ISSUES TO SURGEON. NO DELAY IN SURGERY. NO BROKEN PIECES TO RETRIEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597959 ↗
• MalfunctionSep 9, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT FEMORAL FINISHERS HAVE NICKS AND PIECES MISSING FROM A SAW BLADE HITTING IT. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006352 ↗
• MalfunctionMay 1, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE ATTUNE FEM FINISH GUIDE SZ 6 WAS REPORTED SHARP EDGED DUE TO REPEATED USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943162 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  SULCUS GUIDES ARE WORN DOWN AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543665 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  SULCUS GUIDES ARE WORN DOWN AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543662 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  SULCUS GUIDES ARE WORN DOWN AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543659 ↗
• MalfunctionOct 28, 2024Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  SULCUS GUIDES ARE WORN DOWN AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20543658 ↗
• MalfunctionNov 22, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE INSTRUMENT TO BE WORN. THE PART THAT GUIDES THE SAW IS WORN. AN EXACT CUTTING-PREPARATION IS NO LONGER POSSIBLE. NO ADVERSE PATIENT CONSEQUENCES, NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851224 ↗