ATTUNE 2546-00-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295440154), received between Oct 10, 2019 and May 1, 2024 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMay 1, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE REAMER HAS LITTLE WEAR AND NEEDS REPLACEMENT. UNKNOWN SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220543 ↗
• InjuryOct 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE REVISION REAMING STEP THE PATIENTS POSTERIOR TIBIAL CORTEX WAS VIOLATED. SUBSEQUENT REAMING THROUGH THE POSTERIOR CORTEX WAS REALIZED AND FOUND THAT THE SURGEON MAY HAVE COMPROMISED SOME NEUROVASCULAR STRUCTURES. THE PATIENT WAS CLOSED AFTER SOME VASCULAR REPAIR AND TRANSFERRED TO A LARGER FACILITY FOR MORE SPECIALIZED CARE. NO SURGICAL DELAY. THIS COMPLAINT IS TO CAPTURE THE REAMERS USED IN (B)(4).

  Patient problems: No Code Available

  MAUDE report 9175705 ↗