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

Catalog Number	SPK475
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, spk475, 4.75 mm argo knotless sp anchor, was being used during a rotator cuff procedure on (b)(6) 2025 when it was reported, ¿surgeon inserted and deployed implant and the metal portion of the inserter remained inside the anchor.The surgeon was able to remove this metal portion with a sanp.Surgeon had to use a tool to "yank" broken part out of the patient.Per surgeon: "it done broke".¿ there was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed without an alternate device causing a 5-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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 per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
An examination of the returned used device, item spk475, found the titanium tip detached from the hex driver assembly.Machined screw was detached from the driver assembly and was not returned for the evaluation.Examination was performed per print spk475, rev-c.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive force.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.(b)(4).Per the instructions for use, the user is advised to 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.Avoid any lateral loading while inserting the argo knotless sp anchor.The risk of anchor breakage during implantation is reduced by following the specified instructions for use.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 device, spk475, 4.75 mm argo knotless sp anchor, was being used during a rotator cuff procedure on (b)(6) 2025 when it was reported, ¿surgeon inserted and deployed implant and the metal portion of the inserter remained inside the anchor.The surgeon was able to remove this metal portion with a sanp.Surgeon had to use a tool to "yank" broken part out of the patient.Per surgeon: "it done broke".¿.There was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed without an alternate device causing a 5-minute delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: ARGO
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22456328
• Report Number: 1017294-2025-00083
• Device Sequence Number: 8383626
• Product Code: MBI
• UDI-Device Identifier: 20845854649814
• UDI-Public: (01)20845854649814(17)260924(30)1(10)1450017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 09/24/2026
• Device Catalogue Number: SPK475
• Device Lot Number: 1450017
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic