MAUDE Adverse Event Report: ARTHREX, INC. FW,BPB #2 SUTR,BLU W/NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FW,BPB #2 SUTR,BLU W/NDL
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
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 an arthrex subsidiary employee via (b)(4) that an ar-7200 fiberwire #2 braided polyblend suture was cut when the first knot was made.This was discovered during use with no patient harm.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.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 are such as excessive force applied against a rough surface while cinching the first knot.
Event or Problem Description
Additional information provided: it was further reported that this was discovered during an achilles tendon repair procedure with no delay reported and no additional anesthesia administered.All fragments were retrieved from the patient and the case was completed with another suture.

• Brand Name: FW,BPB #2 SUTR,BLU W/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: 23744028
• Report Number: 1220246-2025-05482
• Device Sequence Number: 8460167
• Product Code: GAT
• UDI-Device Identifier: 00888867041264
• UDI-Public: (01)00888867041264(11)240901(17)290831(10)31710
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 03/23/2026

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: FW,BPB #2 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7200
• Device Lot Number: 31710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown