NA 5400003108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540401809), received between Jul 26, 2023 and Jul 1, 2025 — 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.

• MalfunctionJul 1, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22376652 ↗
• MalfunctionNov 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A FEMORAL OSTEOTOMY PROCEDURE, THE BLADE BROKE AT THE TEETH. IT WAS ALSO REPORTED THAT FRAGMENTS OF THE BROKEN BLADE WERE LEFT IN THE PATIENT, THE FAMILY WAS CONSULTED AND DID NOT CHOOSE TO HAVE A REVISION SURGERY/FRAGMENTS REMOVED AT THIS TIME. IT WAS FURTHER REPORTED THAT THERE WAS NO MEDICAL INTERVENTION AND NO DELAYS AS A RESULT OF THIS EVENT, AND THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20677410 ↗
• MalfunctionJul 26, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398746 ↗