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

Model Number	IMPLANT SYSTEM, FIBERTAK BUTTON
Medical Device Problem Codes	Positioning Failure (1158); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/14/2025, a sales representative reported via email that an ar-3680 fibertak button implant system had a loose anchor sheath on the inserter, making it ultimately too big to implant.They tried tightening the sutures but couldn't get the anchor implanted.The case was completed, and no additional details were provided.This was discovered during a biceps tenodesis procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested on 06/03/2025.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse due to use error/mishandling.
Event or Problem Description
Additional information was received on 06/04/2025: the ar-3680 fibertak button implant system's loose anchor sheath was not visibly loose out of the packaging, and it could have shifted during the implantation process.The case was completed despite the issue with an ar-1662s-1 birmingham biceps implant system.No case delay was reported, and no added anesthesia was administered.No adverse effects were reported before or after the surgery.

• 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: 22140737
• Report Number: 1220246-2025-02363
• Device Sequence Number: 18177756
• Product Code: MBI
• UDI-Device Identifier: 00888867305441
• UDI-Public: (01)00888867305441(11)240416(17)290331(10)15235645
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/13/2025

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: 15235645
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown