MClass TN190-089-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854038994), received between Aug 12, 2026 and Aug 12, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Material Fragmentation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Material Fragmentation

  The distributor reported on behalf of their customer that the MCLASS OSCILLATING SAW BLADE 19 X 0.89 (0.035") X 90 MM, device was being used on 21JUL26 during an unknown procedure when it was reported was reported ¿during the surgery, the tip of this complaint blade was fractured/broken. But the surgeon didn¿t notice the above incident, so the fractured piece of the complaint blade has remained inside of the patient¿s body. There is no plan to remove the fractured piece of the blade at the moment.¿. The procedure was completed and there was no report of medical intervention or extended hospitalization for the patient or user. This report is being raised on the reported injury due patient retaining a foreign body.

  Patient problems: Foreign Body In Patient

  MAUDE report 50220904 ↗