NA 5400003104Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540401779), received between Mar 19, 2019 and Mar 22, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE FIBULA FLAP (BONE REMOVAL FOR MANDIBULAR RECONSTRUCTION), A TOOTH ON THE CUTTING END OF THE BLADE BROKE. THE TOOTH FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT A SECOND BLADE WAS USED AND THE TOOTH ON THE OUTER BLADE ALSO BROKE, THE SURGEON WASHED THE SITE, BUT IS UNSURE IF THE FRAGMENT WAS REMOVED. IT WAS FURTHER REPORTED THAT THE SURGEON TOUCHED THE METAL RETRACTOR WITH THE TWO BLADES IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY MINUTES; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE SECOND BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590839 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE FIBULA FLAP (BONE REMOVAL FOR MANDIBULAR RECONSTRUCTION), A TOOTH ON THE CUTTING END OF THE BLADE BROKE. THE TOOTH FRAGMENT WAS FOUND AND REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT A SECOND BLADE WAS USED AND THE TOOTH ON THE OUTER BLADE ALSO BROKE, THE SURGEON WASHED THE SITE, BUT IS UNSURE IF THE FRAGMENT WAS REMOVED. IT WAS FURTHER REPORTED THAT THE SURGEON TOUCHED THE METAL RETRACTOR WITH THE TWO BLADES IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF TWENTY MINUTES; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16590294 ↗
• MalfunctionMar 19, 2019Break; Break

  IT WAS REPORTED THAT DURING AN OSTEOTOMY PROCEDURE, TWO CUTTING TOOTH FRAGMENTS BROKE FROM THE BLADE. IT WAS ALSO REPORTED THERE WAS A MINOR DELAY AS A RESULT OF THIS EVENT, ONE CUTTING TOOTH WAS RETRIEVED AND DESTROYED AND THE SECOND CUTTING TOOTH REMAINED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432137 ↗