MAUDE Adverse Event Report: ARTHREX, INC. 2-0 FIBERWIRE MENISCUS REPAIR NEEDLES; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2-0 FIBERWIRE MENISCUS REPAIR NEEDLES
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by an arthrex subsidiary employee via email that the needles from an ar-7223 fiberwire meniscus repair were bent.This was discovered during a meniscus repair procedure on (b)(6) 2023.The case was completed using another ar-7223 fiberwire meniscus repair needle from the same lot number.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
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(s) of the reported failure can be user error mishandling the device.The complaint allegation was confirmed based on the customer attached picture that display the needles bent.

• Brand Name: 2-0 FIBERWIRE MENISCUS REPAIR NEEDLES
• 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: emily shafer ; 8009337001
• MDR Report Key: 18100037
• Report Number: 1220246-2023-08615
• Device Sequence Number: 7863025
• Product Code: GAT
• UDI-Device Identifier: 00888867041516
• UDI-Public: 00888867041516
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/10/2025

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 Expiration Date: 10/31/2024
• Device Model Number: 2-0 FIBERWIRE MENISCUS REPAIR NEEDLES
• Device Catalogue Number: AR-7223
• Device Lot Number: 928097788
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2019
• 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