MAUDE Adverse Event Report: ARTHREX, INC. 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-7250, fiberwire® #0 braided polyblend suture, blue w/tapered needle, whilst performing cerclage with 0 fiberwire on an acl graft, the fiberwire outer coating started to shred.This was detected during use in an acl reconstruction procedure on (b)(6) 2025.The procedure was completed successfully as the surgeon continued with the fraying suture.
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.The complaint allegation is confirmed based on the customer-provided picture.The complaint device was not received for evaluation.Visual evaluation of the customer provided photo noted the suture was fraying.Refer to attachments.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/friction during suture passing.

• Brand Name: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• 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: 23088554
• Report Number: 1220246-2025-03930
• Device Sequence Number: 10508898
• Product Code: GAT
• UDI-Device Identifier: 00888867041851
• UDI-Public: (01)00888867041851(11)240501(17)290430(10)31049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 0 FW 38"BLU 22.2 MM W/TAPER PNT NDL
• Device Catalogue Number: AR-7250
• Device Lot Number: 31049
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown