NA 2296033521Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540466709), received between May 22, 2019 and Feb 8, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) PROCEDURE, THREE BLADES BROKE. 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 THIRD BLADE THAT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483520 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) PROCEDURE, THREE BLADES BROKE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13483519 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) PROCEDURE, THREE BLADES BROKE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 13483258 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE. 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 13225155 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE. 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 13224884 ↗
• MalfunctionJan 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE BLADE BROKE. 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 13224827 ↗
• MalfunctionMay 22, 2019Break; Break

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPIC ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE BLADE BROKE IN HALF AS THE TECHNICIAN WAS CLEANING UP AND TAKING THE BLADE OUT OF THE SAW. 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 Consequences Or Impact To Patient

  MAUDE report 8632378 ↗