NA 0298097104Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540897923), received between Jan 13, 2023 and Jan 13, 2023 — classified as 1 injury, 1 malfunction.

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

• MalfunctionJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE AND HAD TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156764 ↗
• InjuryJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE OFF IN THE STERNUM BONE. THE PROCEDURE WAS STOPPED, THE PATIENT¿S LUNGS WERE RE-INFLATED, THE PRODUCT WAS REMOVED, AND A NEW PRODUCT WAS OBTAINED TO FINISH PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; THE DURATION OF THE SURGICAL DELAY WAS NOT REPORTED, AND NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Respiratory Arrest

  MAUDE report 16156762 ↗