NA 5400003412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540401908), received between Nov 6, 2019 and Nov 12, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionNov 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE INSIDE THE PACKAGING. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 9311697 ↗
• MalfunctionNov 6, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A HALLUX VALGUS / SCARF AKIN SURGICAL PROCEDURE, THE BLADE BROKE AT THE CUTTING END. NO FURTHER INFORMATION WAS PROVIDED. IT WAS SUBSEQUENTLY REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. THE WAS FURTHER REPORTED THAT THERE WAS A PROCEDURAL DELAY OF TWO MINUTES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9284407 ↗