NA 2296003104Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540046451), received between Aug 7, 2018 and Oct 21, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionOct 21, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20501017 ↗
• MalfunctionMar 8, 2022Material Discolored; Delivered as Unsterile Product; Material Discolored; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, DURING PREPARATION FOR A SURGERY, THE NURSE NOTICED CONTAMINATION ON THE BLADE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13688867 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED THAT DURING A MPFL (MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION) SURGICAL PROCEDURE, THE BLADE BROKE. IT WAS ALSO REPORTED THAT THE BROKEN FRAGMENT WAS NOTICED DURING X-RAY AND WAS REMOVED FROM 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7757006 ↗