ATTUNE 2545-00-195Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295443094), received between Mar 7, 2021 and Jan 14, 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.

• MalfunctionJan 14, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PIECES OF PLASTIC ARE COMING OFF OF THE DRILL SLEEVE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147399 ↗
• MalfunctionJan 17, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TOP PART OF THE INSTRUMENT HAS SNAPPED OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525567 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED THAT THE REAMER COLLAR FOR SIZE 6-8 NON-CEMENTED REAMER STARTED TO SHED RED PLASTIC DURING REAMING OF TIBIA. ALL PLASTIC SHAVINGS WERE REMOVED AND THERE WAS NO DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11426950 ↗