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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/31/2025
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 11/10/2025, a sales representative reported via email that an ar-1322bcnf mini biocomposite suturetak was implanted in a patient past its expiration date.During the procedure, an anchor pulled out, requiring an increase in anchor size.Unfortunately, the only available options in the shelf inventory were expired, and the surgeon decided to proceed with implanting the expired device.This occurred during a metacarpal fracture/ucl procedure performed on (b)(6) 2025.Additional information was provided via email on 11/19/2025: the anchor that pulled out was an ar-1317ft nano corkscrew ft.The anchor was completely removed from the patient before proceeding to place the expired implant.This added an extra 5¿10 minutes to the case.Due to the extended case time, additional anesthesia was possibly administered, but the sales representative could not confirm.
Additional Manufacturer Narrative
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 of the reported event can be attributed to user error due insufficient fixation of the ar-1317ft nano corkscrew ft anchor, resulting in anchor pullout during the procedure.Contributing factors may include bone quality, misaligned insertion, and/or prying/leveraging the device during insertion.Though these could not be confirmed.

• 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: 23680720
• Report Number: 1220246-2025-05261
• Device Sequence Number: 9846902
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: 00888867276703
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K180118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 1491843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown