NA 4118127090Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540216885), received between May 3, 2019 and Oct 28, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: DELIVERED AS UNSTERILE PRODUCT. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399876 ↗
• MalfunctionOct 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY RECEIVED IN SUCH A MANNER TO INDICATE THAT ITS STERILITY HAD BEEN COMPROMISED. - 2 EVENTS HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569737 ↗
• MalfunctionDec 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, DURING RECEIPT OF THE DEVICE, A HOLE WAS IDENTIFIED IN THE PACKAGING. 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 16018496 ↗
• MalfunctionOct 11, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE, DURING A PROCEDURE, THE POLYBAG DID NOT COMPLETE ASEPTIC TRANSFER AS IT WAS STUCK TO THE INNER PACKAGING SEAL. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576761 ↗
• MalfunctionAug 3, 2022Fracture; Fracture

  IT WAS REPORTED VIA MEDWATCH REPORT (B)(4), THAT DURING A RIGHT TOTAL KNEE ARTHROPLASTY, THE TOOTH BROKE FROM THE CUTTING END OF THE BLADE. IT WAS ALSO REPORTED THAT THE MISSING TOOTH WAS NOT LOCATED, AN X-RAY WAS TAKEN WHICH WAS NEGATIVE FOR FOREIGN BODY. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND NO DELAYS AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157391 ↗
• MalfunctionMay 3, 2019Break; Break

  IT WAS REPORTED THAT THE BLADE BROKE AT THE MOUNT DURING A KNEE REPLACEMENT SURGERY. IT WAS FURTHER REPORTED THAT THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT BLADE. 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 8578531 ↗