MClass TN250-127-90Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10845854021286), received between Jul 27, 2022 and Jul 27, 2022 — 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.

• MalfunctionJul 27, 2022Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TN250-127-90, MCLASS OSC SAW BLADE, WAS BEING USED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿WE HAD A TN250-127-90 BREAK WHILE IN SURGERY THIS AFTERNOON. PIECE WAS FOUND IN PATIENT AND REMOVED AFTER TOTAL KNEE.¿. AN X-RAY WAS TAKEN TO ASSURE ALL PIECES WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT QUESTIONING WAS ASKED, AND A GOOD FAITH EFFORT WAS COMPLETED. WE HAVE NOT RECEIVED ANY FURTHER INFORMATION TO DATE. THE PRO9300B, HALL TITAN OSCILLATING SAW BATTERY HANDPIECE WAS THE DEVICE USED WITH THE BLADE AND WILL BE LISTED AS THE CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111484 ↗