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	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 4/17/2024, 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 and wrist procedure on (b)(6) 2024.When the surgeon was inserting the device, the anchor was stuck to the device's shaft and would not come off.It was tried again, but the anchor did not come off.The device was removed from the patient in one piece, with the anchor stuck to the shaft, and nothing broke off inside the patient.Two ar-8998t nano swivelock suture anchors with fork eyelets with the same lot number were used to complete the case successfully with no harm to the patient.The was a 5-minute case delay, and it could not be confirmed if additional anesthesia was administered to the patient.The complaint device was discarded, and no pictures were taken.This occurred during use with no patient harm.
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.
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 misaligned insertion; prying/leveraging the device during insertion.

• 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: 19297359
• Report Number: 1220246-2024-03155
• Device Sequence Number: 5856000
• Product Code: HWC
• UDI-Device Identifier: 10888867301822
• UDI-Public: 10888867301822
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 04/02/2025

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 SWIVELOCK, 2.5 X 7MM W/ FORK EYELET
• Device Catalogue Number: AR-8998T
• Device Lot Number: 15111297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2023
• 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