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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.H3 other text : device not yet received.
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 (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.
Additional Manufacturer Narrative
An examination of the returned used blade, item tn190-127-05 found blade damaged broken off at the shaft, damage teeth.Broken pieces were returned for evaluation.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be 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.(b)(4).Per the instructions for use, the user is advised to always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.When operating the powerpro electric ii oscillator handpiece, let the saw blade to 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.
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 (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.

• 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: 21046905
• Report Number: 1017294-2024-00166
• Device Sequence Number: 15532882
• Product Code: GFA
• UDI-Device Identifier: 10845854021224
• UDI-Public: (01)10845854021224(17)290507(10)1387853
• 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): 02/03/2025

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: 1387853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic