Hyflex 60018460Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D661600184601), received between Jan 11, 2020 and Jan 11, 2020 — classified as 1 injury.

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. 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.

• InjuryJan 11, 2020Break; Break

  DOCTOR WAS USING OUR HYFLEX CM FILES AND EXPERIENCE SEPARATION IN THE CANAL ON THE FIRST USE OF THE FILE. THE FILE HAD NOT BEEN USED PRIOR TO THIS CASE AND WAS BRAND NEW. DOCTOR COMPLAINS THAT UPON TORSIONAL LOAD OF LESS THAN 2.5NCM (HE HAD HIS TORQUE RATING PROPERLY SET) THE FILE SEPARATED AT THE STOP SECTION. IT DID NOT SEPARATE AT THE MANDREL BUT INSTEAD ABOUT 2MM DOWN FROM WHERE THE SPIRAL PART OF THE FILE BEGINS. IT WAS FILE 04/25 THAT BROKE FROM THE SET. THERE WAS NO PATIENT INJURY. THE CUSTOMER LATER INDICATED THAT THE EVENT HAPPENED DURING PROCEDURE AND HE HAD HAND FILED. HE SAID HE HAND FILES FOR EVERY CASE. THE DOCTOR INDICATED SIZE 15, BUT DID NOT RECALL IF HE USED OUR GLIDEPATH FILE. THE DOCTOR HAD TO BUY A THIRD PARTY INSTRUMENT IN ORDER TO REMOVE THE SEPARATED FILE.

  Patient problems: No Code Available

  MAUDE report 9579310 ↗