MClass TN190-127-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10845854021224), received between Sep 18, 2023 and Aug 7, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Fracture; Fracture

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE TN190-127-05, MCLASS OSCILLATING SAW BLADE 19 X 1.27 (0.050") X 105 MM DEVICE WAS USED IN A TKA PROCEDURE ON (B)(6) 2025, AND ¿THE BLADE BROKE DISTALLY DURING OSTEOTOMY¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN UNKNOWN ALTERNATE ¿BACKUP BLADE¿. FURTHER ASSESSMENT FOUND FRAGMENTS FELL INTO THE SURGICAL SITE AND ALL FRAGMENTS WERE RETRIEVED WITH A FORCEPS-LIKE INSTRUMENT. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 22736990 ↗
• MalfunctionJun 16, 2025Material Separation; Material Separation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE TN190-127-05, MCLASS OSCILLATING SAW BLADE 19 X 1.27 (0.050") X 105 MM DEVICE WAS USED IN A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 21MAY25, AND ¿WHEN USING THIS BLADE TO CUT BONE, THE BASE OF THE BLADE BROKE.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO REPORTED DELAY. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE. ALL FRAGMENTS WERE REMOVED WITH A "FORCEPS-LIKE INSTRUMENT". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. 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 22212637 ↗
• MalfunctionDec 31, 2024Material Separation; Material Separation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE TN190-127-05, MCLASS OSCILLATING SAW BLADE 19 X 1.27 (0.050") X 105 MM DEVICE WAS USED IN A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024, AND ¿THIS BLADE BROKE IN THE TIP AND MIDDLE PART DURING USE. IT WAS USED IN TKA AND THE BLADE WAS REPORTEDLY BROKEN DURING A OSTEOTOMY.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE AND ALL FRAGMENTS WERE "RETRIEVED WITH AN INSTRUMENT SUCH AS FORCEPS". THE PROCEDURE WAS COMPLETED WITHOUT THE USED OF AN ALTERNATE DEVICE, AND NO DELAY. THERE WAS NO INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THE PATIENT'S CURRENT STATUS IS "NO ISSUES". 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 21046905 ↗
• MalfunctionOct 25, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TN190-127-05, MCLASS OSCILLATING SAW BLADE 19 X 1.27 (0.050") X 105 MM WAS BEING USED AND ¿BROKE DURING A TKA. THE SURGEON WAS PERFORMING A CUT TO THE PATIENT¿S FEMUR WHEN THE BLADE BROKE UNEXPECTEDLY INSIDE OF THE JIG. THERE WAS NO HARM TO THE PATIENT OR STAFF, AND ONLY A MINOR DELAY TO THE CASE.¿. ALL FRAGMENTS WERE RETRIEVED FROM THE SURGICAL SITE. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20534341 ↗
• MalfunctionAug 8, 2024Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, TN190-127-05, MCLASS OSC SAW BLADE 19MM X 1.27MM (0.050 INCH) X 105MM, WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THIS BLADE BROKE IN THE MIDDLE PART DURING USE.¿. FURTHER ASSESSMENT FOUND THAT THE DEVICE FRAGMENTED INTO THE PATIENT AND THE FRAGMENTATION WAS RETRIEVED WITH A ¿FORCEPS-LIKE¿ INSTRUMENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937414 ↗
• MalfunctionOct 23, 2023Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TN190-127-05, MCLASS OSC SAW BLADE 19MM X 1.27MM (0.050 INCH)X 105MM WAS BEING USED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED ¿THIS BLADE BROKE IN THE TIP AND MIDDLE PART DURING USE. IT WAS USED IN TKA AND THE BLADE WAS REPORTEDLY BROKEN DURING OSTEOTOMY.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE FRAGMENTED INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF FORCEP LIKE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND NO DELAY WAS REPORTED. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿THERE IS NO PROBLEM¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED 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 17986398 ↗
• MalfunctionSep 18, 2023Material Fragmentation; Material Fragmentation

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE TN190-127-05, MCLASS OSC SAW BLADE 19MM X 1.27MM (0.050 INCH) X 105MM WAS BEING USED IN A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023 AND THAT "THIS BLADE BROKE IN THE TIP AND MIDDLE PART DURING USE. IT WAS USED IN TKA AND THE BLADE WAS REPORTEDLY BROKEN DURING A POSTERIOR FEMORAL OSTEOTOMY. THE HANDPIECE WAS A PRO9350 / TITAN PRIMECUT OSCILLATING SAW AND WAS USED IN HIGH SPEED MODE¿. PER ASSESSMENT, A FRAGMENT FELL INTO THE SURGICAL SITE AND WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE AND WITH NO REPORTED DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION FOR THE PATIENT. 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 17765997 ↗