MAUDE Adverse Event Report: CONMED LARGO Y-KNOT PRO RC ANCHOR, TWO RIBBONS; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	YPRC02R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The conmed japan reported on behalf of the customer that the yprc02r y-knot pro rc anchor, two ribbons device was being used on (b)(6) 2024 on when it was reported ¿the fork at the tip of the inserter broke.The fragment retrieved from the patient body.¿ there was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported 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 for trends through the complaint system to assure patient safety.
Event or Problem Description
The conmed japan reported on behalf of the customer that the yprc02r y-knot pro rc anchor, two ribbons device was being used on (b)(6) 2024 on when it was reported ¿the fork at the tip of the inserter broke.The fragment retrieved from the patient body.¿.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device has not been returned to date 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.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 2 complaints, regarding 2 devices, for this device family and failure mode.During this same time frame 81,259 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 0.00002.Per the instructions for use, the user is advised preoperative and operating procedures, including knowledge of surgical techniques and proper selection and placement of implants, are important considerations in the successful utilization of these devices.Surgeon must choose proper implant size based on specific procedure and patient history.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: Y-KNOT PRO RC ANCHOR, TWO RIBBONS
• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 19309340
• Report Number: 1017294-2024-00057
• Device Sequence Number: 19585651
• Product Code: MBI
• UDI-Device Identifier: 20845854648923
• UDI-Public: (01)20845854648923(17)281210(10)1358881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133224
• 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): 06/07/2024

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: YPRC02R
• Device Lot Number: 1358881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic