MAUDE Adverse Event Report: ARTHREX, INC. NANO CORKSCREW FT, TI, W 3-0 FW; NON-DEGRADABLE FIXATN FASTENER

Model Number	NANO CORKSCREW FT, TI, W 3-0 FW
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 11/19/2025, an arthrex subsidiary employee reported via email that the screw from an ar-1317ft nano corkscrew ft suture anchor broke during surgery.All fragments were retrieved.The procedure was completed using a replacement ar-1317ft nano corkscrew ft suture anchor.No specific details were provided regarding the type of surgery, bone preparation, or bone quality.There was no significant delay, no additional anesthesia administered, and no adverse effects noted.No photographs were taken to document the event.This was discovered during a procedure on (b)(6) 2025, with no reported patient harm.Additional information was received on 11/25/2025: this issue occurred during the insertion of the anchor into the bone hole.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is user error, resulting from one or more of the following factors: improper bone preparation, excessive impaction, misaligned insertion, and/or prying or levering during use, which led to the device/screw breaking.Directions for use dfu-0087-eo revision 6 corkscrew®, pushlock®, and swivelock® suture anchors g.Precautions: 3.Make sure to use the recommended drill bit or punch to create the bone socket.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: NANO CORKSCREW FT, TI, W 3-0 FW
• 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: 23757226
• Report Number: 1220246-2025-05504
• Device Sequence Number: 10170422
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: (01)00888867276703(11)250603(17)300531(10)15445799
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180118
• 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): 03/12/2026

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: NANO CORKSCREW FT, TI, W 3-0 FW
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 15445799
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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