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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 6/21/2024, it was reported by a sales representative via phone that an ar-8998t nano swivelock suture anchor with fork eyelet had an issue during a hand scapula reconstruction procedure.After insertion, when the surgeon was trying to advance the device, the anchor was spinning and stuck to the shaft.The shaft and anchor were removed from the patient in one piece, and nothing broke inside the patient.Another three ar-8998t nano swivelock suture anchors with fork eyelet with batch number 15165966 were used to complete the procedure successfully with no harm to the patient.There was a slight case delay of under 15 minutes and no additional anesthesia was administered.The complaint device was discarded and no pictures were taken.This occurred during use with no reported patient harm.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information g3, h3, h6.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 for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• 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: 20063689
• Report Number: 1220246-2024-07257
• Device Sequence Number: 8662890
• Product Code: HWC
• UDI-Device Identifier: 10888867301822
• UDI-Public: 10888867301822
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/13/2025

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 Expiration Date: 09/30/2026
• Device Model Number: NANO SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Device Catalogue Number: AR-8998T
• Device Lot Number: 14357379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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