MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED KNOTLESS FTAK, KNEE 1-PACK; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LOADED KNOTLESS FTAK, KNEE 1-PACK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/27/2025, a sales representative reported via email that one of the fork-like tips on the ar-3740sp-1 double loaded knotless knee fibertak inserter was missing when the insertion handle was removed.This was discovered during a let procedure on (b)(6) 2025.Additional information was received on 10/30/2025: the anchor remained in the patient following the procedure.A single prong from the tip of the anchor inserter also remained inside the patient.Despite this, the case was completed as planned without any complications or delays using a new ar-3740sp-1 double loaded knotless knee fibertak.There was no delay in surgery, and no additional anesthesia was administered to the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation is confirmed.One unpackaged ar-3740sp-1 serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage of the device.Visual inspection noted that the tip of the device is broken off and was not returned.The most likely cause is attributed to misuse/use error due to excessive force.Per the directions for use (dfu): dfu-0054-eo, bio-fastak, fastak¿, suturetak® and fibertak® suture anchors, g.Precautions "5.Insert the anchor with the same orientation as that of the prepared drilled bone hole to avoid damage to the anchor or inserter.6.Suturetak and fibertak suture anchors only: anchors loaded on flexible drivers: the drill guide tip must remain in contact with the bone surface during the drilling and implant impaction steps of the procedure.Failure to do so may result in difficulty seating the implant to its intended depth.Avoid excessive impaction during anchor insertion as this could lead to inserter damage and/or breakage.If insertion resistance is encountered, do not impact harder.Replace the implant and repeat the drilling/insertion process.".

• Brand Name: DBL LOADED KNOTLESS FTAK, KNEE 1-PACK
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 23466475
• Report Number: 1220246-2025-04992
• Device Sequence Number: 21052680
• Product Code: MBI
• UDI-Device Identifier: 00888867428058
• UDI-Public: (01)00888867428058(11)241202(17)291130(10)15355420
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: DBL LOADED KNOTLESS FTAK, KNEE 1-PACK
• Device Catalogue Number: AR-3740SP-1
• Device Lot Number: 15355420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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