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

Catalog Number	TN190-127-05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event cannot be verified.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 one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 20 reports, regarding 20 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised to not apply excessive loading on the shaver blade or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure, and overheating.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 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.

• 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: 22212637
• Report Number: 1017294-2025-00072
• Device Sequence Number: 8620597
• Product Code: GFA
• UDI-Device Identifier: 10845854021224
• UDI-Public: (01)10845854021224(17)280423(10)1313853
• 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
• Report Date (Section B): 06/16/2025

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: 1313853
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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