MAUDE Adverse Event Report: ARTHREX, INC. FW BPB #5 SUTR,BLU W/NDL; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FW BPB #5 SUTR,BLU W/NDL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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 (b)(6) 2025, it was reported by a sales representative via (b)(4) that (qty.2) of an ar-7211 fiberwire #5 braided polyblend suture broke during use.No pieces broke off in the patient.The case was completed successfully.This was discovered during a quad repair procedure on (b)(6) 2025, with no reported patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.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 the most likely cause.The most likely cause of the reported failure is user error, specifically damage caused by crushing or crimping due to the use of surgical instruments such as forceps or needle holders.The complaint allegation was confirmed based on the customer's attached image, which shows a blue suture with frayed tips, a missing curved needle, and filaments protruding from the suture strand.

• Brand Name: FW BPB #5 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: 21356475
• Report Number: 1220246-2025-00380
• Device Sequence Number: 8959834
• Product Code: GAT
• UDI-Device Identifier: 00888867041417
• UDI-Public: (01)00888867041417(11)230901(17)280831(10)29460
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: FW BPB #5 SUTR,BLU W/NDL
• Device Catalogue Number: AR-7211
• Device Lot Number: 29460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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