MAUDE Adverse Event Report: ARTHREX, INC. KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS; ARTHROSCOPIC ACCESSORIES

Model Number	KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/10/2025, a sales representative reported via phone that an ar-3653ttsp knotless 2.6 fibertak® rc soft anchors repair stitch would not shuttle through.This occurred during a rotator cuff repair on (b)(6) 2025.The anchor remains in the patient, and the suture was cut out.There was a delay of about ten minutes where additional anesthesia was not administered.There was no harm to the patient.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, incorrect surgical technique during the knotless mechanism conversion process, and/or an excessive force applied during suture passing/tightening /tensioning.

• Brand Name: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23682578
• Report Number: 1220246-2025-05287
• Device Sequence Number: 9847001
• Product Code: MBI
• UDI-Device Identifier: 00888867370081
• UDI-Public: (01)00888867370081(11)230825(17)280731(10)15133500
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 Model Number: KL FBTK RC,(BLK/BLU)FT & (BLU/BLK)#2 MTS
• Device Catalogue Number: AR-3653TTSP
• Device Lot Number: 15133500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown