NA 4118127100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04546540216892), received between Feb 15, 2017 and Jul 26, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 16, 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.

• MalfunctionJul 26, 2023Fracture; 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 17397042 ↗
• MalfunctionSep 16, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE AT THE MOUNT. 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 15439046 ↗
• MalfunctionMar 11, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY(THA) SURGERY, THE BLADE BROKE. IT WAS ALSO REPORTED THAT ALL BLADE FRAGMENTS WERE RETRIEVED SUCCESSFULLY. IT WAS FURTHER REPORTED 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 9819970 ↗
• MalfunctionFeb 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT A BLADE BROKE DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SPARE BLADE. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676534 ↗
• MalfunctionJan 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE AT THE TEETH DURING A TOTAL HIP ARTHROPLASTY PROCEDURE. 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 9558407 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED 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 7701668 ↗
• InjuryFeb 15, 2017Break; Break

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE, TWO BLADES BROKE. IT WAS ALSO REPORTED THAT THE FIRST BLADE THAT BROKE WAS A REPROCESSED BLADE AND THE SURGEON REMOVED THE FRAGMENT FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE SECOND BLADE BROKE AT THE CUTTING END, AN X-RAY WAS TAKEN WHICH CONFIRMED THE FRAGMENT WAS NOT IN THE PATIENT¿S BODY. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR THE FIRST BLADE THAT BROKE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 6331484 ↗