MAUDE Adverse Event Report: ARTHREX, INC. 2-0 FIBERSTICK, 2-0 FIBERWIRE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2-0 FIBERSTICK, 2-0 FIBERWIRE
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 02/29/2024, it was reported by a sales representative via e-mail that an ar-7222 #2-0 fiberstick did not cut.This occurred during a tctr procedure; they placed the threads without problems, but when they tried to use the sawing back and forth motion to cut the ligament, nothing happened.The ar-7222 slid back and forth across the ligament but would not cut.The procedure had to be abandoned.Additional information was provided on 03/05/2024, where the sales representative reported that this event occurred during an ultrasound-guided carpal tunnel release on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: b3, 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 of the reported failure can be attributed to user error when using the knot pusher/suture cutter due to the suture was not able to be cut.

• Brand Name: 2-0 FIBERSTICK, 2-0 FIBERWIRE
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 18923776
• Report Number: 1220246-2024-01539
• Device Sequence Number: 7682748
• Product Code: GAT
• UDI-Device Identifier: 00888867041509
• UDI-Public: 00888867041509
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 06/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2-0 FIBERSTICK, 2-0 FIBERWIRE
• Device Catalogue Number: AR-7222
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown