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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a sales representative reported via phone that an ar-1317ft nano corkscrew's driver tines at the top of the shaft broke off.Piece broke off into patient and retrieved, new device opened and case completed with no patient effect.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• 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 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50804177
• Report Number: 1220246-2026-04787
• Device Sequence Number: 12910716
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180118
• 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
• Report Date (Section B): 09/17/2026

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: 15636662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2026
• 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