ATTUNE 2545-00-346Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295446439), received between Dec 27, 2022 and Sep 25, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionSep 25, 2026Material Deformation

  It was reported that the ATTUNE LOW-PROF TIB PIN PULLER bent at the front. There was no reported patient or user harm. There was no significant delay. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897523 ↗
• MalfunctionJan 4, 2023Break; Break

  IT WAS REPORTED THAT THE TIBIAL IMPACTOR WAS FOUND BY SSD TO HAVE A SPLIT FROM TOP TO BOTTOM ON THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095152 ↗
• MalfunctionDec 27, 2022Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  LOT/BATCH/EXP: UNKNOWN. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT. THE TIBIAL IMPACTOR WAS FOUND BY SSD TO HAVE A SPLIT FROM TOP TO BOTTOM ON THE SIDE. THE LOW PROFILE PIN WAS BLUNT AND WORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16057061 ↗