MAUDE Adverse Event Report: CONMED LARGO 4.75MM ARGO KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	K475
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported event is inconclusive.The device will not be returned for evaluation and no photographic evidence has been 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.(b)(4).Per the instructions for use, the user is advised the following: ensure use of proper bone preparation instrumentation including drill bit and punch for non-self-punching anchors.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.Avoid any lateral loading while inserting the argo knotless¿ anchor.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 device, k475, 4.75mm argo knotless anchor, was being used on approximately (b)(6) 2021 during a rotator cuff repair procedure and the ¿tip was broken during anchor insertion.¿ there was no report of impact or injury to the patient.There was maybe a 5 minute delay to locate and remove the piece and the procedure was completed with a backup.After further assessment it was found, ¿the tip did fall into the incision site, we were able to retrieve the broken tip and upon inspection it we were able to fit both parts back together to ensure there were no other smaller pieces.The piece was retrieved using a grasp.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.75MM ARGO KNOTLESS ANCHOR
• 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: 12858282
• Report Number: 1017294-2021-00361
• Device Sequence Number: 11849934
• Product Code: MBI
• UDI-Device Identifier: 20845854649821
• UDI-Public: (01)20845854649821(17)230317(30)1(10)1194409
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K163258
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 03/17/2023
• Device Model Number: K475
• Device Catalogue Number: K475
• Device Lot Number: 1194409
• 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: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic