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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 06/11/2024, it was reported by a sales representative via e-mail that an ar-1317ft suture anchors plastic insert holding the screw on would not slide up.This occurred during a tissue repair on (b)(6) 2024 the surgeon went to go insert the anchor and the plastic insert holding the screw on would not slide up.The surgeon tried to back the screw up a little to see if that would release the plastic, but it still was stuck to the inserter.She ended up just advancing the screw all the way and pulling on the plastic, which then, caused parts of the metal screw to fray off.The anchor and metal pieces were removed from the patient, and a new corkscrew was inserted just fine.Additional information received on 6/18/2024: everything was removed from the patient and the case was completed using a new ar-1317ft nano corkscrew ft.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos provided.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• 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: 19688513
• Report Number: 1220246-2024-06609
• Device Sequence Number: 12792703
• Product Code: MBI
• UDI-Device Identifier: 00888867276703
• UDI-Public: 00888867276703
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 04/03/2025

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: NANO CORKSCREW FT, TI, W 3-0 FW
• Device Catalogue Number: AR-1317FT
• Device Lot Number: 15024390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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