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

Model Number	KL FBTK RC, (WH/BLK)TT & (BLU)#2 MTS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2025
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 (b)(6) 2025, a sales representative reported via email that an ar-3653tsp knotless 2.6 fibertak rc soft anchor and two ar-3653sp knotless 2.6 fibertak rc soft anchors failed to deploy.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 12/24/2025: during a rotator cuff repair procedure, one ar-3653tsp knotless 2.6 fibertak rc soft anchor and two ar-3653sp knotless 2.6 fibertak rc soft anchors pulled out of the bone but remained intact, with no fragments left behind.The procedure was completed using ar-2324bcc biocomposite swivelock c suture anchor and ar-2323bcc biocomposite swivelock suture anchor.The event resulted in a 10¿15-minute delay, requiring additional anesthesia for the same duration.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including improper bone preparation and/or improper surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: KL FBTK RC, (WH/BLK)TT & (BLU)#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: 23958720
• Report Number: 1220246-2026-00053
• Device Sequence Number: 14855358
• Product Code: MBI
• UDI-Device Identifier: 00888867370043
• UDI-Public: (01)00888867370043(11)250203(17)300131(10)15382602
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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, (WH/BLK)TT & (BLU)#2 MTS
• Device Catalogue Number: AR-3653SP
• Device Lot Number: 15382602
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown