MAUDE Adverse Event Report: ARTHREX, INC. 0 FW 38" WHITE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	0 FW 38" WHITE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 11/19/2025, it was reported by a distributor via (b)(6) that a qty.4 of (b)(4) fiberwire #0 sutures broke when being passed through the meniscus by an (b)(4) knee scorpion as the clamp did not grip the suture and broke it in the center.This was discovered during use with no patient harm reported.
Additional Manufacturer Narrative
Based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors, such as improper loading of the sutures or applying excessive force when passing the suture.

• Brand Name: 0 FW 38" WHITE
• 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: 23707274
• Report Number: 1220246-2025-05317
• Device Sequence Number: 10641857
• Product Code: GAT
• UDI-Device Identifier: 00888867121041
• UDI-Public: (01)00888867121041(11)250317(17)290430(10)15227752
• Combination Product (Y/N): N
• 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): 03/16/2026

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: 0 FW 38" WHITE
• Device Catalogue Number: AR-7255
• Device Lot Number: 15227752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown