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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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
It was reported that during a rotator cuff surgery the anchor did not hold.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: d2a, d2b, d9, g3, h2, h3, h6.One unpackaged ar-1317ft-1, batch 15296229, was received for investigation.Upon evaluation, the device's tip was damaged.Additionally, the suture assembly was returned torn/damaged.Functional testing could not be performed due to the damage to the device.The most likely cause of the reported failure is user error, such as misaligned insertion and/or prying/leveraging the device during use.Refer to investigation photos.The complaint allegation is 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: 21753581
• Report Number: 1220246-2025-01173
• Device Sequence Number: 8235646
• Product Code: MBI
• UDI-Device Identifier: 00888867287549
• UDI-Public: (01)00888867287549(11)240801(17)290731(10)15296229
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K180118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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-1
• Device Lot Number: 15296229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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