MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK BICEPS IMPLANT; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK BICEPS IMPLANT
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a distributor reported via email that an ar-3671 fibertak biceps implant had one needle skewered through the suture tape of another suture, causing tangling straight out of the box.This was noticed after insertion when the implant was unwoven from the inserter.The needle was unskewered, and the procedure continued without further issue.This was discovered during a biceps tenodesis / cuff procedure on (b)(6) 2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 user error, including mishandling the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: FIBERTAK BICEPS IMPLANT
• 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: 23906711
• Report Number: 1220246-2025-05858
• Device Sequence Number: 15751620
• Product Code: MBI
• UDI-Device Identifier: 00888867305403
• UDI-Public: (01)00888867305403(11)250709(17)300630(10)15463455
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K251809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: FIBERTAK BICEPS IMPLANT
• Device Catalogue Number: AR-3671
• Device Lot Number: 15463455
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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