MAUDE Adverse Event Report: CONMED LARGO Y-KNOT FLEX 1.3MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y1301
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
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 sales representative reported on behalf of the customer, that the y1301, y-knot flex 1.3mm all-suture anchor lot number 1238822 was being used during a btb procedure on (b)(6) 2023 date when it was reported ¿1.3 mm yknot flex & 1.8mm yknot flex each one got damaged while performing a surgery.¿.Further assessment questioning found that the device did fragment and was removed with the use of an arthroscopic grasper.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization to the patient or user.The y1802a, y-knot flex 1.8mm all-suture anchor lot number 1309633 will be listed as a concomitant device.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not being returned and the photographic evidence provided does not appear to verify the complaint; therefore, a device malfunction 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.A two-year review of complaint history revealed there has been a total of 10 complaints, regarding 12 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 that 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.
Event or Problem Description
The sales representative reported on behalf of the customer, that the y1301, y-knot flex 1.3mm all-suture anchor lot number 1238822 was being used during a btb procedure on 21aug23 date when it was reported ¿1.3 mm yknot flex & 1.8mm yknot flex each one got damaged while performing a surgery.¿ further assessment questioning found that the device did fragment and was removed with the use of an arthroscopic grasper.The procedure was completed and there was no report of injury, medical intervention or extended hospitalization to the patient or user.The y1802a, y-knot flex 1.8mm all-suture anchor lot number 1309633 will be listed as a concomitant device.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: Y-KNOT FLEX 1.3MM ALL-SUTURE 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17728246
• Report Number: 1017294-2023-00083
• Device Sequence Number: 6542837
• Product Code: MBI
• UDI-Device Identifier: 20845854021658
• UDI-Public: (01)20845854021658(17)270409(10)123822
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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: Y1301
• Device Lot Number: 1238822
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Y1802A, Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR; Y1802A, Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic