NA 2296003108S5Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154631827), received between Apr 30, 2021 and Dec 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A FOOT AND ANKLE PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938746 ↗
• MalfunctionDec 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A FOOT AND ANKLE PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15938744 ↗
• 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 11757410 ↗