MAUDE Adverse Event Report: ARTHREX, INC. 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the customer-provided picture.Visual evaluation of the customer provided photo noted the needle of an ar-7229-12-1 fiberloop® braided polyblend suture 4-0/ 1.5 metric 12'' (30.5 cm), blue, looped, taper point needle had detached from the suture.Based on the information provided, 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 passing/tightening/tensioning.
Event or Problem Description
It was reported that during a tendon surgery the needle eyelet broke while passing through suture and also broke the suture while pulling it.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a third party suture.It was not necessary to switch the surgical technique or do a second surgery.Update: (b)(6) 9-jul-2025.Further information was received that confirms the original description.The needle eyelet broke and it damaged the suture.

• Brand Name: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• 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: 22637946
• Report Number: 1220246-2025-03101
• Device Sequence Number: 18526103
• Product Code: GAT
• UDI-Device Identifier: 00888867280632
• UDI-Public: (01)00888867280632(11)240101(17)281231(10)30224
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/28/2025

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: 4-0 FIBERLOOP, 12 INCHES WITH NEEDLE
• Device Catalogue Number: AR-7229-12-1
• Device Lot Number: 30224
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown