MAUDE Adverse Event Report: CONMED LARGO ARGO KNOTLESS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	K475
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
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
The sales representative reported on behalf of the customer, that k475, 4.75 mm argo knotless anchor was being used on (b)(6) 2024 during a rotator cuff repair procedure when it was reported ¿weld broke and hex was floating around in the shoulder, caused 5¿10-minute case delay.¿.Further assessment found that the fragment was removed with the use of graspers.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.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 k475, 4.75 mm argo knotless anchor was being used on (b)(6) 2024 during a rotator cuff repair procedure when it was reported ¿weld broke and hex was floating around in the shoulder, caused 5¿10-minute case delay.¿.Further assessment found that the fragment was removed with the use of graspers.The procedure was completed and there was no report of injury, medical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned; however photographic evidence was provided.The root cause cannot be determined, however, based upon the photos and the ifu, the likely cause of this event was excessive force on side bending/loading combined with overloading the device.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 1 device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of two complaints, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised not to load more than the recommended maximum number of suture, ribbon, or tape into the suture anchor or breakage may occur.Inspect all instruments for damage prior to and after each use.Ensure the anchor tip is properly seated on the driver tip prior to and during implantation.Ensure the free ends of the suture securely fit into the suture cleat on the driver handle.Exercise care in the use of the device to minimize side or bending loads.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: ARGO KNOTLESS
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 20309694
• Report Number: 1017294-2024-00111
• Device Sequence Number: 8866476
• Product Code: MBI
• UDI-Device Identifier: 20845854649821
• UDI-Public: (01)20845854649821(17)250826(30)1(10)1372967
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K163258
• 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): 11/05/2024

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: 08/26/2025
• Device Catalogue Number: K475
• Device Lot Number: 1372967
• 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: 09/09/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic