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	10/31/2025
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 per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the k475, 4.75 mm argo knotless anchor was being used on 31oct25 during an rcr and the ¿surgeon was finishing his cuff repair using a 4.75mm argo (k475 - 1443004).He had passed x2 ribbons though the cuff for the medial row and then anchored all 4 limbs of ribbon into this argo.He had pre-punched with a disposable punch (k4755dtbp - 1457856) which worked well.He removed the argo after screwing the anchor in which worked great.When he used the katana suture cutter to cut the limbs of suture, he moved the camera back to the working site where he could see the katana working and noticed a free metal piece.At first he thought the katana had come apart but it was the end of the argo that had dislodged from the anchor when he removed the handle.He wasn't worried.We checked the repair and the anchor was working well like it should.We then made sure that was all that was missing and took photos of the anchor and the dislodged piece.Procedure was completed when this incident happened.We ensured no metal was left in the patient." there was no report of impact or injury to the patient and this event did not cause a delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event 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.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 3 reports, regarding 3 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: inspect all instruments for damage prior to and after each use.Avoid any lateral loading while inserting the argo knotless anchor.Maintain proper alignment during insertion of the anchor and disengagement of the driver.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the k475, 4.75 mm argo knotless anchor was being used on (b)(6) 2025 during an rcr and the ¿surgeon was finishing his cuff repair using a 4.75mm argo (k475 - 1443004).He had passed x2 ribbons though the cuff for the medial row and then anchored all 4 limbs of ribbon into this argo.He had pre-punched with a disposable punch (k4755dtbp - 1457856) which worked well.He removed the argo after screwing the anchor in which worked great.When he used the katana suture cutter to cut the limbs of suture, he moved the camera back to the working site where he could see the katana working and noticed a free metal piece.At first, he thought the katana had come apart but it was the end of the argo that had dislodged from the anchor when he removed the handle.He wasn't worried.We checked the repair and the anchor was working well like it should.We then made sure that was all that was missing and took photos of the anchor and the dislodged piece.Procedure was completed when this incident happened.We ensured no metal was left in the patient." there was no report of impact or injury to the patient and this event did not cause a delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 23541418
• Report Number: 1017294-2025-00114
• Device Sequence Number: 9719281
• Product Code: MBI
• UDI-Device Identifier: 20845854649821
• UDI-Public: (01)20845854649821(17)260823(30)1(10)1443004
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K251530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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 Expiration Date: 08/23/2026
• Device Catalogue Number: K475
• Device Lot Number: 1443004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2025
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic