ATTUNE 2545-11-194Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295499282), received between Jan 15, 2025 and Apr 8, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT RED CIRCLE STOP BROKE. ALL PIECES WERE COLLECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821559 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT ONE OF THE RED TABS ON THE AFFIXIUM DRILL STOP BROKE OFF AND CAN NO LONGER BE USED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506048 ↗
• MalfunctionJan 15, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT WERE REPORTED FOR UNKNOWN REASONS. THE EVENT DID NOT HAPPEN IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162386 ↗