NA 5400134285Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540729675), received between Oct 19, 2020 and Nov 4, 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.

• MalfunctionNov 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING OPEN HEART SURGERY, THE BLADE BROKE AT THE MOUNT. 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 15736673 ↗
• MalfunctionJun 24, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A STERNOTOMY PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE MISSING TIP WAS RECOVERED AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800454 ↗
• MalfunctionOct 19, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE DURING A REDO-STERNOTOMY AT THE BLADE MOUNT. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND A DELAY OF TWO MINUTES 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 10701230 ↗