MAUDE Adverse Event Report: ARTHREX, INC. HYBRID FIBERTAK WITH NEEDLES, KNEE; NON-DEGRADABLE FIXATN FASTENER

Model Number	HYBRID FIBERTAK WITH NEEDLES, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2025
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 16-dec-2025, it was reported by an arthrex employee via email that an ar-3770sp hybrid knee fibertak anchor experienced an issue during use.After drilling a pilot hole, the anchor was inserted to the specified depth.When the anchor shaft was removed, the tip of the shaft was found to be broken.The broken piece could not be retrieved.Despite this, the anchor functioned without further issues and was used as is, allowing the procedure to be completed successfully.No significant surgery delay was reported, and no additional anesthesia was administered.This issue was discovered during a lateral epicondyle of the femur step in a knee extratendonotomy (let) procedure on (b)(6) 2025.
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 use error, including improper bone preparation and/or excessive mechanical forces, misalignment, and/or prying or levering of the device during insertion.Dfu-0054-eu-04-eo revision 2 -fibertak® suture anchors k.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.Replace the implant and repeat the drilling/insertion process.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: HYBRID FIBERTAK WITH NEEDLES, 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: 23960897
• Report Number: 1220246-2026-00067
• Device Sequence Number: 14859242
• Product Code: MBI
• UDI-Device Identifier: 00888867428065
• UDI-Public: (01)00888867428065(11)250728(17)300630(10)15473318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,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: HYBRID FIBERTAK WITH NEEDLES, KNEE
• Device Catalogue Number: AR-3770SP
• Device Lot Number: 15473318
• 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: 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown