NA 0298097101Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540169600), received between Sep 6, 2022 and Sep 6, 2022 — classified as 2 malfunctions.

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.

• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT 2000330000-2022-8042 THAT THE STERNAL SAW BLADE BROKE IN HALF WHILE THE SURGEON WAS SAWING/OPENING THE STERNUM. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 15362328 ↗
• MalfunctionSep 6, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH 2000330000-2022-8043, THAT DURING A CORONARY ARTERY BYPASS GRAFT, WHILE SAWING THE STERNUM, THE BLADE BROKE IN HALF. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES 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 15362321 ↗