MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK, TRIPLOAD FW BL/W, BLK/W, W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK, TRIPLOAD FW BL/W, BLK/W, W
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
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 02/14/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-3631-1 fibertak¿ rc suture anchor loosened.This occurred during use they followed all the steps of the technique.During suturing, the anchor loosened and another anchor had to be opened to complete the procedure.
Additional Manufacturer Narrative
Additional information: 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 misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: FIBERTAK, TRIPLOAD FW BL/W, BLK/W, W
• 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: 21468744
• Report Number: 1220246-2025-00674
• Device Sequence Number: 14305386
• Product Code: MBI
• UDI-Device Identifier: 00888867276895
• UDI-Public: (01)00888867276895(11)240715(17)290630(10)15287645
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: FIBERTAK, TRIPLOAD FW BL/W, BLK/W, W
• Device Catalogue Number: AR-3631-1
• Device Lot Number: 15287645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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