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

Model Number	IMPLANT SYSTEM, FIBERTAK BUTTON
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2025
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 phone that an ar-3680 fibertak® button implant systems second stitch would not pull through the anchor.This occurred during a rotator cuff biceps tenodesis on (b)(6) 2025, the device remained in the patient and the second stitch was tied to the first stitch over the tendon.This resulted in a five-minute delay and it is unknown if additional anesthesia was administered.
Additional Manufacturer Narrative
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 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: IMPLANT SYSTEM, FIBERTAK BUTTON
• 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: 23632968
• Report Number: 1220246-2025-05169
• Device Sequence Number: 9381578
• Product Code: MBI
• UDI-Device Identifier: 00888867305441
• UDI-Public: (01)00888867305441(11)250730(17)300630(10)15475259
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K191426
• 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): 03/06/2026

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: IMPLANT SYSTEM, FIBERTAK BUTTON
• Device Catalogue Number: AR-3680
• Device Lot Number: 15475259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2025
• 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