NA 72203519Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885554027846), received between May 4, 2023 and Oct 28, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE INCISOR PLUS BLADE PLASTIC CASING WAS CRACKED AND THEREFORE UNSTERILE ON ARRIVAL. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547534 ↗
• InjuryMay 4, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE DYONICS INCISOR BLADE LEFT A LOT OF METAL DEBRIS IN THE JOINT. MOST OF THE METAL DEBRIS WAS RETRIEVED FROM THE PATIENT WITH SUCTION. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S CURRENT STATUS IS WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 16870991 ↗