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

Model Number	IMPLANT SYSTEM, FIBERTAK BUTTON
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/22/2025, a sales representative reported via email that an ar-3680 fibertak button implant system was inserted into the bone during a procedure.After the tendon was whipstitched, the surgeon attempted to convert the shuttling sutures, at which point the anchor pulled out of the bone.To complete the case, the surgeon implanted an ar-2290, which was inserted without difficulty.The patient was not injured as a result of the failure; however, additional anesthesia was administered.No photos or videos were captured to document the device failure.This issue was identified during the procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 08/28/2025: the issue was identified during a biceps tenodesis procedure on (b)(6) 2025.The case was delayed for one minute, with one minute of additional anesthesia administered to the patient.
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.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error of the device due to improper surgical technique during the knotless mechanism conversion process, misalignment insertion and/or excessive force used during suture passing/tightening /tensioning.

• 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: 23032190
• Report Number: 1220246-2025-03821
• Device Sequence Number: 21205124
• Product Code: MBI
• UDI-Device Identifier: 00888867305441
• UDI-Public: (01)00888867305441(11)250123(17)291231(10)15376986
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/05/2025

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: 15376986
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown