MAUDE Adverse Event Report: CONMED LARGO MCLASS; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	TN190-127-05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
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.
Additional Manufacturer Narrative
Reported event of ¿blade broke¿ was confirmed.The device will not be returned for evaluation, but photographic evidence has been provided.A root cause cannot be determined; however, based upon evaluation of the device, a possible cause of this event could be the use of excessive force.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of 1 device for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised the following: do not stall handpieces, damage can occur.Precaution: when operating the powerpro electric ii oscillator handpiece, let the saw blade do the cutting.Too much force will bind the blade which can damage the handpiece.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: MCLASS
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22736990
• Report Number: 1017294-2025-00094
• Device Sequence Number: 21142304
• Product Code: GFA
• UDI-Device Identifier: 10845854021224
• UDI-Public: (01)10845854021224(17)291218(10)1430121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TN190-127-05
• Device Lot Number: 1430121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic