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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 10/08/2025, an arthrex subsidiary employee reported via (b)(4) that (qty.2) ar-3631-1 fibertak triple-loaded suture anchors detached from the greater tuberosity during a shoulder arthroscopy.The technique was correctly performed.One of the anchors had its suture completely damaged.An additional anchor was used and inserted after drilling a new hole with the fibertak cuff drill and guide.No patient was affected.
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 allegation is confirmed.Based on the photographic evidence provided of a damaged ar-3631-1 anchor, batch 15368145 along with any available information such as the returned device (if applicable), photographs, videos, event description, and additional field input arthrex has determined the most likely cause.The most likely cause is attributed to misuse, specifically excessive tension during insertion, improper seating, misaligned insertion, or prying/leveraging the device during use.

• 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: 23300480
• Report Number: 1220246-2025-04606
• Device Sequence Number: 10027812
• Product Code: MBI
• UDI-Device Identifier: 00888867276895
• UDI-Public: (01)00888867276895(11)250103(17)291231(10)15368145
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 15368145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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