NA 2296033520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540466693), received between Apr 30, 2021 and Apr 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THREE BLADES BROKE WHERE IT FITS INTO THE HANDPIECE. IT WAS ALSO REPORTED THERE WAS A DELAY OF 10MINUTES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO ADVERSE CONSEQUENCES OCCURRED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE THREE BLADES WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757407 ↗
• MalfunctionApr 30, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THREE BLADES BROKE WHERE IT FITS INTO THE HANDPIECE. IT WAS ALSO REPORTED THERE WAS A DELAY OF 10MINUTES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO ADVERSE CONSEQUENCES OCCURRED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS RECORD ADDRESSES ONE OF THE THREE BLADES WHICH WERE REPORTED TO HAVE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11757382 ↗