NA 2296003412Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04546540046604), received between Aug 19, 2021 and Mar 9, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A PROCEDURE, BLADE PACKAGING HAD A HOLE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 16515544 ↗
• MalfunctionJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BLADE BROKE AT THE TEETH. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 16156772 ↗
• MalfunctionJan 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BLADE BROKE AT THE TEETH. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 16156767 ↗
• MalfunctionDec 13, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION 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 15971757 ↗
• MalfunctionAug 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A MEDICAL PROCEDURE, THE BLADE BROKE AT THE CUTTING END. IT WAS ALSO REPORTED THAT THE SURGEON REMOVED THE BROKEN FRAGMENTS WITH SALINE LEAVING THE SITE FREE OF FOREIGN PARTICLES, WHICH RESULTED IN AN UNKNOWN DELAY. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341960 ↗