ATTUNE 2545-01-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295395515), received between Aug 28, 2020 and May 20, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2025Break; Break

  THE DEVICE WAS REPORTED FOR A CHIPPED INSTRUMENT. IT DIDN'T HAPPEN IN SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22054640 ↗
• MalfunctionOct 26, 2021Break; Break

  IT WAS REPORTED THAT THE PATELLA DRILL TRIALS SPIKES ARE MISSING. RECEIVED TRAY WITH PATELLA TRIALS MISSING THE SPIKES. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700583 ↗
• MalfunctionAug 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE CONNECTION BETWEEN THE ATTUNE PATELLA DRILL CLAMP (2545-01-055) AND THE MEDIALIZED DOME PATELLA DRILL TRIAL (E.G., 2545-01-048) WAS NOT AS STABLE AS REQUIRED. THE DRILL TRIAL REPEATEDLY SLIPPED OFF THE DRILL CLAMP UPON SQUEEZING THE DRILL CLAMP. THE ISSUE WAS CIRCUMVENTED BY MANUALLY STABILIZING THE DRILL TRIAL ON THE DRILL CLAMP UPON SQUEEZING THE DRILL CLAMP.

  Patient problems: No Code Available

  MAUDE report 10466577 ↗