MAUDE Adverse Event Report: CONMED LARGO MCLASS OSC SAW BLADE 25MM X 1.27MM (0.050 INCH) X 90MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	TN250-127-90
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the tn250-127-90, mclass osc saw blade, was being used during a total knee procedure on (b)(6) 2022 when it was reported, ¿we had a tn250-127-90 break while in surgery this afternoon.Piece was found in patient and removed after total knee.¿.An x-ray was taken to assure all pieces were removed from the patient.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning was asked, and a good faith effort was completed.We have not received any further information to date.The pro9300b, hall titan oscillating saw battery handpiece was the device used with the blade and will be listed as the concomitant device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The sales representative reported on behalf of the customer that the tn250-127-90, mclass osc saw blade, was being used during a total knee procedure on 11jul22 when it was reported, ¿we had a tn250-127-90 break while in surgery this afternoon.Piece was found in patient and removed after total knee.¿.An x-ray was taken to assure all pieces were removed from the patient.There was no report of injury, medical intervention, or hospitalization for the patient.Further assessment questioning was asked, and a good faith effort was completed.We have not received any further information to date.The pro9300b, hall titan oscillating saw battery handpiece was the device used with the blade and will be listed as the concomitant device.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Confirmation of breakage via photographic evidence.The blade was thoroughly investigated for manufacturing defects; however, none were found.All critical dimensions and material properties of the device were within specification.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 6 complaints, regarding 6 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 do not use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may occur.Avoid contact of blades with cutting blocks, retractors or other instrumentation.Damage to blade or instrumentation may occur.Metal fragments may cause injury to patient or user.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: MCLASS OSC SAW BLADE 25MM X 1.27MM (0.050 INCH) X 90MM
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15111484
• Report Number: 1017294-2022-00084
• Device Sequence Number: 17502232
• Product Code: GFA
• UDI-Device Identifier: 10845854021286
• UDI-Public: (01)10845854021286(17)270307(10)1232257
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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 Model Number: TN250-127-90
• Device Catalogue Number: TN250-127-90
• Device Lot Number: 1232257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRO9300B, SAW BATTERY HANDPIECE; PRO9300B, SAW BATTERY HANDPIECE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic