MAUDE Adverse Event Report: ARTHREX, INC. NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET; BONE FIXATION SCREW/PLATE

Model Number	NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/25/2025
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 11/26/2025, a sales representative reported via email that two ar-8998t nano swivelock suture anchors with fork eyelet experienced an issue during a scapholunate repair procedure performed on (b)(6) 2025.While inserting a 2.5 mm nano swivelock anchor, the titanium portion of the anchor cold-welded to the inserter, making removal from the bone difficult.When force was applied to extract the anchor, a fragment of the scaphoid bone fractured.The issue was identified during use.Additional information was received on (b)(6) 2025: during the scapholunate repair procedure, two ar-8998t nano swivelock suture anchors with fork eyelet (2.5 x 7 mm) experienced cold-welding during final advancement.The bone tunnel was not tapped before insertion, and the patient¿s bone quality was assessed as hard.Both anchors were retrieved from the patient, and all fragments were accounted for with nothing remaining inside.As a result of the issue, the surgeon drilled a second hole and used different anchors, including two ar-8998t nano swivelock suture anchors with fork eyelet (2.5 x 7 mm) and an ar-8998ds disposable kit, nano swivelock (2.5 x 7 mm).The repair was completed as planned without the need for additional fixation; however, dbx was used to backfill the bone loss in the tunnel.The case was delayed by approximately 45 minutes, and it is uncertain whether additional anesthesia was administered.No adverse effects were reported during or after the procedure, and no additional surgery is planned at this time.
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 a user error, including improper bone preparation and/or improper surgical technique associated with the device.Directions for use (b)(4), corkscrew, pushlock, and swivelock suture anchors.C.Contraindications: 1.Insufficient quantity or quality of bone.G.Precautions: 3.Make sure to use the recommended drill bit or punch to create the bone socket.The complaint allegation that the anchor was cold-welded to the inserter cannot be confirmed, as the device was not returned for evaluation.The customer¿s attached picture shows the anchor on the inserter with damage to the threads; however, it is not possible to determine from the image whether the anchor is cold-welded to the inserter tip.

• Brand Name: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 23826994
• Report Number: 1220246-2025-05653
• Device Sequence Number: 8954720
• Product Code: HWC
• UDI-Device Identifier: 00888867301825
• UDI-Public: (01)00888867301825(11)250820(17)300731(10)15485794
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191651
• 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): 03/31/2026

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 SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Device Catalogue Number: AR-8998T
• Device Lot Number: 15485794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2025
• 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