MAUDE Adverse Event Report: CONMED LARGO MCLASS OSC SAW BLADE 19MM X 1.27MM (0.050 INCH) X 105MM; GFA - BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	TN190-127-05
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
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 for trends through the complaint system to assure patient safety.
Event or Problem Description
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
Examination of the returned used blade found the blade damaged at the teeth and broken off at the hub.Broken pieces were returned for evaluation.The likely cause of this issue is the application of excessive force during use and/ or bending the blade out of the plane of the cut and/ or contact with other metallic instruments.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 9 reports, regarding 9 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 the following: 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.Avoid contact of blades with cutting blocks, retractors or other instrumentation.Damage to blade or instrumentation may occur.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: MCLASS OSC SAW BLADE 19MM X 1.27MM (0.050 INCH) X 105MM
• Common Device Name: GFA - 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 17765997
• Report Number: 1017294-2023-00085
• Device Sequence Number: 7093813
• Product Code: GFA
• UDI-Device Identifier: 10845854021224
• UDI-Public: (01)10845854021224(17)280426(10)1314592
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 1314592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRO9350 / TITAN PRIMECUT OSCILLATING SAW; PRO9350 / TITAN PRIMECUT OSCILLATING SAW
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic