MAUDE Adverse Event Report: CONMED LARGO Y-KNOT; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	YRC02
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported on behalf of a customer that the yrc02, rc all-suture anchor,with hi-fi sutures device was used in a shoulder joint procedure on (b)(6) 2025, and ¿during the shoulder joint surgery, when the screw was being inserted, the front end of the instrument broke, causing the thread bundle to fall off and become unusable.The surgery was completed by replacing it with a new device.¿.Further assessment found that ¿the front end of the instrument¿ referred to ¿tip of the inserter¿, and the term ¿broke¿ meant ¿cracked¿.The customer also indicated that the device fragmented and fell into the surgical site.All fragments were retrieved with forceps.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, and the patient's current status is "recovered".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
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
A distributor reported on behalf of a customer that the yrc02, rc all-suture anchor,with hi-fi sutures device was used in a shoulder joint procedure on (b)(6) 2025, and ¿during the shoulder joint surgery, when the screw was being inserted, the front end of the instrument broke, causing the thread bundle to fall off and become unusable.The surgery was completed by replacing it with a new device.¿.Further assessment found that ¿the front end of the instrument¿ referred to ¿tip of the inserter¿, and the term ¿broke¿ meant ¿cracked¿.The customer also indicated that the device fragmented and fell into the surgical site.All fragments were retrieved with forceps.There was no injury, medical/surgical intervention or extended hospitalization required for the patient, and the patient's current status is "recovered".This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not 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.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 five reports, regarding five 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 to inspect instruments prior to use to ensure they are in good physical condition and function properly.There should be no loose, broken or misaligned parts.Exercise care in the use of these devices to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instruments after use to ensure they have not been damaged.Instruments are designed for use by surgeons experienced in the appropriate specialized procedures.It is the responsibility of the surgeon to become familiar with the proper techniques for use.Ensure y-knot anchors are properly seated on driver tips prior to and during implantation.Avoid lateral loading while inserting y-knot anchors.Maintain proper alignment during insertion of anchors and disengagement of drivers.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 LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22456666
• Report Number: 1017294-2025-00084
• Device Sequence Number: 15483491
• Product Code: MBI
• UDI-Device Identifier: 20845854080549
• UDI-Public: (01)20845854080549(11)240709(10)1399222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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 Catalogue Number: YRC02
• Device Lot Number: 1399222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic