NA XFR004222Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252265719), received between May 27, 2025 and May 27, 2025 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryMay 27, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT: "WE HAD AN INCIDENT TODAY WHERE ONE OF THE ANCHORAGE 1 REAMERS CAUSED HARM TO THE PATIENT BY DAMAGING THE BONE, RESULTING IN A NEED FOR A BONE GRAFT. IT SEEMS THE REAMERS USED WERE BLUNT." "MTP FUSION SURGERY, BEGAN REAMING OF THE PROXIMAL PHALANX AND AS THE REAMER CAME INTO CONTACT WITH THE BONE IT CAUSED THE DISTAL 2/3'S OF THE PROXIMAL PHALANX ON THE DORSAL ASPECT TO BECOME DAMAGED".

  Patient problems: Insufficient Information

  MAUDE report 22087143 ↗