ATTUNE 2545-02-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295489221), received between Apr 21, 2025 and Apr 9, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Break; Crack

  IT WAS REPORTED THAT THE DEVICE IS CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832127 ↗
• MalfunctionApr 9, 2026Break; Crack

  IT WAS REPORTED THAT THE DEVICE IS CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831935 ↗
• MalfunctionApr 8, 2026Break; Crack

  IT WAS REPORTED THAT THE DEVICE IS CHIPPING AND CRACKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821728 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem

  IT WAS REPORTED THAT THE LUG DRILL BECAME STUCK IN LUG HOLE OF FEMORAL TRIAL. IT WAS REMOVED AND THE CASE PROCEEDED AS PLANNED, HOWEVER IT DOES APPEAR THAT LUG DRILL AND FEMORAL TRIAL ARE DAMAGED AND THE SURGEON WOULD LIKE THEM REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22708100 ↗
• MalfunctionApr 28, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE DEVICE IS SCUFFED AND CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918716 ↗
• MalfunctionApr 21, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE DEVICE IS SCUFFED AND CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875951 ↗
• MalfunctionApr 21, 2025Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THE ITEMS WERE SCUFFED AND CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872533 ↗