MAUDE Adverse Event Report: CONMED LARGO 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED, QTY 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	5052-179
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5116554 on (b)(6) 2023.The report was found to be written against the 00505217900, 12.5 x 76 x 0.9mm reciprocator blade, coated device that was being used during an unknown procedure on (b)(6) 2023.The report stated, ¿patient admitted after a fall and found to have a femoral neck fracture.After the procedure it was noted that there was a small piece of the saw blade left inside the patient incision.Piece was removed.An xray was confirmed no additional pieces were left in the incision.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention, or hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report mw5116554 on 19apr23.The report was found to be written against the 00505217900, 12.5 x 76 x 0.9mm reciprocator blade, coated device that was being used during an unknown procedure on 09mar23.The report stated, ¿patient admitted after a fall and found to have a femoral neck fracture.After the procedure it was noted that there was a small piece of the saw blade left inside the patient incision.Piece was removed.An xray was confirmed no additional pieces were left in the incision.¿.Further assessment questions were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention, or hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 2 complaints for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 24 complaints, regarding 30 devices, for this device family and failure mode.During this same time frame 1,837,009 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 0.00002.Per the instructions for use, the user is advised to not use burs for plunge cutting.Injury or damage may occur.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.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: 12.5 X 76 X 0.9MM RECIPROCATOR BLADE, RIBBED, COATED, QTY 5
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16897557
• Report Number: 1017294-2023-00041
• Device Sequence Number: 6091797
• Product Code: GFA
• UDI-Device Identifier: 10845854000649
• UDI-Public: (01)10845854000649(17)250223(10)1081611
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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 Expiration Date: 02/23/2025
• Device Model Number: 5052-179
• Device Catalogue Number: 00505217900
• Device Lot Number: 1081611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2020
• 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