MAUDE Adverse Event Report: ARTHREX, INC. 4-0 FIBERLOOP, 20 INCHES WITH NEEDLE; POLYETHYLENE SYNTHETIC SUTURE

Model Number	4-0 FIBERLOOP, 20 INCHES WITH NEEDLE
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, it was reported by an arthrex subsidiary employee via email that an ar-7229-20 fiberloop was frayed.This was discovered upon opening the package during a procedure on (b)(6) 2024.The case was completed using another ar-7229-20 fiberloop.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 4-0 FIBERLOOP, 20 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: 19987985
• Report Number: 1220246-2024-07175
• Device Sequence Number: 7075351
• Product Code: GAT
• UDI-Device Identifier: 00888867041608
• UDI-Public: 00888867041608
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/14/2024

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, 20 INCHES WITH NEEDLE
• Device Catalogue Number: AR-7229-20
• Device Lot Number: 28596
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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