MAUDE Adverse Event Report: ARTHREX, INC. FIBERLOOP; POLYETHYLENE SYNTHETIC SUTURE

Model Number	FIBERLOOP
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 an arthrex employee via email that for 2 units of ar-7234c, fiberloop® #2, braided polyblend suture, blue, looped, with curved needle, 40'' (101,6 cm), 20'' working length, the nitinol wire broke from suture.This was detected during use in a bicep tenodesis procedure on (b)(6) 2025.The procedure was completed successfully with a mayo needle.
Additional Manufacturer Narrative
Additional information: 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 for the reported failure can be attributed to user error of the device due to excessive force used during suture tightening /tensioning.

• Brand Name: FIBERLOOP
• 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: 22998628
• Report Number: 1220246-2025-03750
• Device Sequence Number: 15806081
• Product Code: GAT
• UDI-Device Identifier: 00888867041691
• UDI-Public: (01)00888867041691(11)250415(17)290430(10)15221442
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 12/18/2025

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: FIBERLOOP
• Device Catalogue Number: AR-7234C
• Device Lot Number: 15221442
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/19/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown