MAUDE Adverse Event Report: CONMED MClass; Blade, Saw, General & Plastic Surgery, Surgical

Catalog Number	TN190-089-90
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of their customer that the mclass oscillating saw blade 19 x 0.89 (0.035") x 90 mm, device was being used on 21jul26 during an unknown procedure when it was reported was reported ¿during the surgery, the tip of this complaint blade was fractured/broken.But the surgeon didn¿t notice the above incident, so the fractured piece of the complaint blade has remained inside of the patient¿s body.There is no plan to remove the fractured piece of the blade at the moment.¿.The procedure was completed and there was no report of medical intervention or extended hospitalization for the patient or user.This report is being raised on the reported injury due patient retaining a foreign body.
Additional Manufacturer Narrative
G3 initial awareness date was 02aug26.The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.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; 525 french road; utica NY 13502
• Manufacturer (Section G): CONMED Largo; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; +1(315)223-0184
• MDR Report Key: 50220904
• Report Number: 1017294-2026-00152
• Device Sequence Number: 18721056
• Product Code: GFA
• UDI-Device Identifier: 10845854038994
• UDI-Public: (01)10845854038994(17)301103(10)1505592
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TN190-089-90
• Device Lot Number: 1505592
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown