ATTUNE 2546-00-427Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295440239), received between Aug 5, 2022 and Aug 31, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026No Apparent Adverse Event

  It was reported that the instrument had an unknown allegation and it did not happen in surgery.During manufacturer's investigation of the returned device it was identified that the ATUN REV TIB STRGHT STEM WRNCH had signs of heavy usage over time, such as, multiple impaction marks, scratches, deformation of the edges and washing stains.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525588 ↗
• MalfunctionAug 31, 2026No Apparent Adverse Event

  It was reported that the instrument had an unknown allegation and it did not happen in surgery.During manufacturer's investigation of the returned device it was identified that the ATUN REV TIB STRGHT STEM WRNCH had signs of heavy usage over time, such as, multiple impaction marks, scratches, deformation of the edges and washing stains.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525583 ↗
• MalfunctionAug 31, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525580 ↗
• MalfunctionAug 31, 2026No Apparent Adverse Event

  It was reported that the device had an unknown allegation. It did not happened in surgery.During manufacturer's investigation of the returned device it was identified that the ATUN REV TIB STRGHT STEM WRNCH had signs of heavy usage over time, such as, multiple impaction marks, scratches, deformation of the edges and washing stains.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525467 ↗
• MalfunctionAug 5, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WRENCH WAS SPRUNG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176169 ↗