MAUDE Adverse Event Report: CONMED Y-KNOT; Fastener, Fixation, Nondegradable, Soft Tissue

Catalog Number	Y1301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Conmed japan reported on behalf of the customer that the y1301 flex 1.3mm allsuture anch w/1-#2 wht/bl (5metric) hi-fi sutr, was found after post-operative care when a peroneus superior retinaculum repair (das-de method) procedure was performed on an unknown date when it was reported, ¿a y-knot flex anchor (1.3 mm diameter, with one no.2 suture) was inserted into the tibia.It has been approximately seven months since the surgery, yet the patient continues to experience persistent bone pain at the anchor insertion site.¿.Further assessment questioning confirmed that the device did not malfunction during this procedure.The patient had no pathological conditions of bone, no restriction for healing and no foreign body sensitivities.The procedure was completed and it was also reported ¿according to the doctor, they will monitor the situation for about a year and then reassess whether removal is necessary.¿.There was no report of medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported injury due to the patient obtaining post operative pain at the insertion site.
Additional Manufacturer Narrative
G3 initial awareness date was 13aug26.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.

• Brand Name: Y-KNOT
• Common Device Name: Fastener, Fixation, Nondegradable, Soft Tissue
• Manufacturer (Section D): CONMED; 525 french road; utica NY 13502
• Manufacturer (Section G): CONMED Largo; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; +1(315)223-0184
• MDR Report Key: 50614234
• Report Number: 1017294-2026-00159
• Device Sequence Number: 18818909
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)300706(10)1475928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Y1301
• Device Lot Number: 1475928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown