MAUDE Adverse Event Report: CONMED LARGO Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	Y1802
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Conmed japan reported on behalf of the customer that the y1802, y-knot flex 1.8mm all-suture anchor device was being used during a knee meniscus preservation surgery procedure on (b)(6) 2024 when it was reported ¿y1802 was used for knee centralization under doctors¿ surgery.At that time, the fork part at the tip of the inserter was damaged.Damaged metal remains in the body.¿ further assessment questioning found that there was no delay reported and there was no medical/surgical intervention.Currently, it is unknown if there are any plans to remove the fragment from the patient.The procedure was completed without the use of an alternate device.The current status if the patient was reported as unknown.This report is being raised on the reported injury due to the patient retaining a foreign body.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.\ we will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
Additional Manufacturer Narrative
Damaged metal remains in the body¿ was confirmed.Customer complaint was confirmed.Examination of the returned used device, item y1302 confirm the reported problem and found broken off one of the anchor forks.Broken tip was not returned for evaluation.Anchor shaft found slightly bent.Root cause cannot be determined, however, based upon evaluation of the device; a possible cause of this event could be excessive force.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 4 complaints, regarding 4 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 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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of the customer that the y1802, y-knot flex 1.8mm all-suture anchor device was being used during a knee meniscus preservation surgery procedure on (b)(6) 2024 when it was reported ¿y1802 was used for knee centralization under doctors¿ surgery.At that time, the fork part at the tip of the inserter was damaged.Damaged metal remains in the body.¿.Further assessment questioning found that there was no delay reported and there was no medical/surgical intervention.Currently, it is unknown if there are any plans to remove the fragment from the patient.The procedure was completed without the use of an alternate device.The current status if the patient was reported as unknown.This report is being raised on the reported injury due to the patient retaining a foreign body.

• Brand Name: Y-KNOT FLEX 1.8MM 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: 18639316
• Report Number: 1017294-2024-00015
• Device Sequence Number: 7731935
• Product Code: MBI
• UDI-Device Identifier: 20845854021672
• UDI-Public: (01)20845854021672(17)280728(10)1331947
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131035
• 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): 03/20/2024

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: Y1802
• Device Lot Number: 1331947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic