MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a sales representative reported via phone that an ar-3637 knotless 1.8 fibertak implant system's anchor tip snapped in half during insertion.The broken pieces were retrieved from the patient.An ar-3636 knotless 1.8 fibertak soft anchor was used to complete the case.There was no case delay, and it is uncertain if added anesthesia was administered.No adverse effects were reported.This was discovered during a labrum repair procedure on (b)(6) 2025, with no reported patient harm.
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.Based on the information provided, which may include the returned device (if available), photographs, videos, event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to misaligned insertion, improper bone preparation, and/or prying or levering of the device during insertion.

• Brand Name: KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
• 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: 23425451
• Report Number: 1220246-2025-04893
• Device Sequence Number: 9799079
• Product Code: MBI
• UDI-Device Identifier: 00888867459403
• UDI-Public: (01)00888867459403(11)250731(17)300531(10)15475772
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K221396
• 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): 02/25/2026

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: KNOTLESS 1.8 FIBERTAK IMPLANT SYSTEM
• Device Catalogue Number: AR-3637
• Device Lot Number: 15475772
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown