MClass TN190-137-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854039137), received between May 31, 2023 and May 31, 2023 — classified as 1 malfunction.

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.

• MalfunctionMay 31, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TN190-137-05, MCLASS OSC SAW BLADE 19MM X 1.37M (0.054 IN) X 105MM, WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿THIS BLADE BROKE IN THE MIDDLE PART DURING USE. THE FRAGMENT WAS RETRIEVED WITH THE USE OF A "FORCEP-LIKE INSTRUMENT.". THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND WITHOUT THE USE OF AN ALTERNATE DEVICE. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS "THERE IS NO PROBLEM AT THIS TIME.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17030404 ↗