Nano fx® FURS-4101Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M528FURS41010), received between Sep 5, 2024 and Sep 5, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Flaked” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Flaked; Flaked

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ARTHROSURFACE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 13AUGUST2024 IT WAS REPORTED TO ANIKA THAT DURING AN ANKLE PROCEDURE ON A PATIENT OF UNKNOWN AGE AND DEMOGRAPHIC, THE SURGEON WAS GOING TO MALLET THE NEEDLE INTO THE PATIENT'S BONE OFF AXIS. THE DEVICE SLIPPED RESULTING IN CARTILAGE DAMAGE. THE SURGEON REPORTED WHAT APPEARED TO BE A METALLIC FLAKE IN THE PATIENT'S JOINT SPACE. THE FLAKE WAS REPORTEDLY CLEANED OUT. THE SURGEON STOPPED USING THE DEVICE. THERE WAS NO REPORT OF A DEVICE DEFICIENCY. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT OR USER IMPACT. THERE WAS NO REPORT OF A DELAY IN THE PROCEDURES. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. THIS IS ONE OF TWO REPORTS BEING SUBMITTED FOR EACH COMPONENT USED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS SOLICITED.

  Patient problems: Abrasion; Foreign Body In Patient

  MAUDE report 20146961 ↗