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

Catalog Number	YP1802
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/04/2026
Type of Reportable Event	Serious Injury
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 yp1802, y-knot pro flex 1.8 mm anchor, two no.2 hi-fi device was used in a surgery for recurrent shoulder dislocation on (b)(6) 2026, and ¿the normal drill bit was implanted with an open circuit, and the angle was not deviated.However, the opening at the head end broke.¿.The procedure was completed with an alternate device and a delay of one hour.Further assessment found the device fragmented and fell into the surgical site and fragments were not retrieved."the fragments have already penetrated into the bones and are difficult to remove.The hospital has communicated with the patient to obtain their understanding and will conduct regular follow-ups after the surgery.".The patient was hospitalized as "a normal postoperative hospital stay, not because of the fracture of the equipment.".The patient's status is described as "in clinical communication and understanding".This report is being raised due to the reported injury of retained foreign body.
Additional Manufacturer Narrative
Reported event ¿head end broke - device fragmented and fell into the surgical site but fragments were not retrieved¿ was confirmed.The device will not be returned for evaluation, however, photographic evidence has been provided.Root cause cannot be determined, however, based upon photos; 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.(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.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 yp1802, y-knot pro flex 1.8 mm anchor, two no.2 hi-fi device was used in a surgery for recurrent shoulder dislocation on (b)(6) 2026, and "the normal drill bit was implanted with an open circuit, and the angle was not deviated.However, the opening at the head end broke." the procedure was completed with an alternate device and a delay of one hour.Further assessment found the device fragmented and fell into the surgical site and fragments were not retrieved."the fragments have already penetrated into the bones and are difficult to remove.The hospital has communicated with the patient to obtain their understanding and will conduct regular follow-ups after the surgery." the patient was hospitalized as "a normal postoperative hospital stay, not because of the fracture of the equipment." the patient's status is described as "in clinical communication and understanding".This report is being raised due to the reported injury of retained foreign body.

• Brand Name: Y-KNOT
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• 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: 24176418
• Report Number: 1017294-2026-00011
• Device Sequence Number: 13167624
• Product Code: MBI
• UDI-Device Identifier: 20845854050689
• UDI-Public: (01)20845854050689(17)300118(10)1436213
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K131035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: YP1802
• Device Lot Number: 1436213
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2025
• 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