NA 1100000000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540024978), received between Aug 19, 2019 and Nov 18, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN AUTOPSY PROCEDURE, WHEN OPENING THE SKULL, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THE USER WAS NOT AWARE THAT THE BLADE IS A SINGLE USE BLADE.

  Patient problems: No Patient Involvement

  MAUDE report 9335426 ↗
• MalfunctionNov 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN AUTOPSY PROCEDURE, WHEN OPENING THE SKULL, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS A FEW MINUTES DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS ALSO REPORTED THAT THE USER WAS NOT AWARE THAT THE BLADE IS A SINGLE USE BLADE.

  Patient problems: No Patient Involvement

  MAUDE report 9335332 ↗
• MalfunctionAug 19, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING SET PREPARING FOR OPENING A CRANIUM DURING AN AUTOPSY, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THIS SINGLE USE BLADE WAS USED TEN TIMES.

  Patient problems: No Patient Involvement

  MAUDE report 8905773 ↗