AMF REVISION TT CONES 906C.21.818Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390189569), received between Jul 15, 2024 and Jul 15, 2024 — classified as 1 malfunction.

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

• MalfunctionJul 15, 2024Break; Break

  INTRA-OPERATIVE ISSUE DUE TO BREAKAGE HAPPENED ON (B)(6) 2024. IT WAS NOT THE FIRST TIME IT WAS USED; THE CONSIGNMENT SET INVOLVED HAS BEEN USED PROBABLY 5-10 TIMES. THE INSTRUMENTS INVOLVED IN THE EVENT ARE THE FOLLOWING: REAMING SHAFT (PART CODE 906C.10.800, LOT NUMBER 22BQ01Y). CENTRAL TIBIA REAMER HEAD D.18 (PART CODE 906C.21.818, LOT 22BG037). THERE WAS NO IMPACT ON SURGERY (ABOUT 10 MINUTES DELAY) AND THE SURGEON WAS ABLE TO WORK AROUND IT, BECAUSE WHEN THE SHAFT WENT THROUGH THE REAMER, HE HAD COMPLETED REAMING AND WAS ABLE TO PLACE THE IMPLANT. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746262 ↗