ATTUNE 2545-01-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295395539), received between Oct 21, 2019 and Apr 23, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT 35 DRILL GUIDE DEVICE GOT BONDED UP IN THE LUG DRILL AND DID NOT SEAT PROPERLY. THE 35 PATELLA TRIAL, THE PLASTIC PEG NUBBIN CHIPPED OFF AND DID NOT SEAT PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971260 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED THAT IMPACTED PRODUCTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522930 ↗
• 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 12700566 ↗
• MalfunctionApr 28, 2021Material Deformation; Material Deformation

  PATELLA DRILLS BENT/NOT ATTACHING TO INSTRUMENT HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739870 ↗
• MalfunctionOct 21, 2019Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE SPIKES ON BACK OF PATELLA DRILL GUIDE ARE DULL. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215261 ↗