Tréphine Ø12 / Trephine Ø12 265573Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03661489655739), received between Nov 9, 2021 and Nov 9, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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.

• MalfunctionNov 9, 2021Material Fragmentation; Material Fragmentation

  DURING A ARTHRODESIS PROCEDURE, THE CALCANAIL TREPHINE BROKE AT ITS DISTAL END WHEN PASSING THROUGH THE JOINT TO PLACE THE NAIL. THIS INCIDENT RESULTED IN THE RELEASE OF 9 METAL FRAGMENTS INTO THE PATIENT WHICH HAD TO BE RECOVERED. THE SURGEON WAS ABLE TO REMOVE ALL THE FRAGMENTS FROM THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779720 ↗