NA 2296003206Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540046536), received between Mar 2, 2020 and Mar 2, 2020 — 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.

• MalfunctionMar 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL TRANSFER PROCEDURE, TWO BLADES BROKE. IT WAS ALSO REPORTED THAT AN X-RAY WAS PERFORMED TO CONFIRM THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. 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. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774226 ↗
• MalfunctionMar 2, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TIBIAL TRANSFER PROCEDURE, TWO BLADES BROKE. IT WAS ALSO REPORTED THAT AN X-RAY WAS PERFORMED TO CONFIRM THERE WERE NO FRAGMENTS REMAINING IN THE PATIENT. 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. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774225 ↗