ATTUNE 2504-40-603Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295438427), received between Jul 22, 2019 and Jan 31, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2020Material Twisted/Bent; Material Twisted/Bent

  SURGEON TRIED TO OVER-TIGHTEN SCREWS ATTACHING THE 1-3 BROACH ADAPTER TO SIZE 3 AP CUTTING BLOCK. IN DOING SO, APPEARS TO HAVE CROSS-THREADED THE LEFT HAND SCREW OF THE BROACH ADAPTER AND THREAD ON INSIDE OF AP CUTTING BLOCK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9656018 ↗
• MalfunctionJul 22, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HEADED PIN BECAME STUCK IN SIZE 3 REVISION CUT BLOCK. ALL PIECES WERE RETRIEVED AND THE SURGERY WAS NOT DELAYED. RETURNING BLOCK WITH PIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811815 ↗