MAUDE Adverse Event Report: ARTHREX, INC. DOUBLE LOADED KNOTLESS FIBERTAK, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on photographic evidence showing a fractured tip of an ar-3740sp fibertak®, batch 15473019.Based on the information provided ¿ which may include the returned device (if available), photographs, videos, the event description, and any additional field input ¿ arthrex has determined the most likely cause of the reported damage.The damage is most likely due to misuse, including application of excessive force, misaligned insertion, and/or prying or leveraging the device during use.Per dfu-0054-eo bio-fastak, fastak¿, suturetak® and fibertak® suture anchors section e.Warnings.7.¿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.".
Event or Problem Description
It was reported that during a lateral extra-articular tenodesis surgery in the knee the tip of the inserter broke off on insertion.The broken part remained in the patient, since it was securely embedded in the bone.The anchor of the inserter was still deployed and was used successfully to finish the surgery.The surgeon also noted that the patient wasn't stable as he malleted the anchor in, the knee moved which put the fork tips under excessive force resulting in breakage.Per complaint reporter there was no harm for patient, operator or third party.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• 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: 24280809
• Report Number: 1220246-2026-00459
• Device Sequence Number: 15533327
• Product Code: MBI
• UDI-Device Identifier: 00888867428041
• UDI-Public: (01)00888867428041(11)250728(17)300630(10)15473019
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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: DOUBLE LOADED KNOTLESS FIBERTAK, KNEE
• Device Catalogue Number: AR-3740SP
• Device Lot Number: 15473019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown