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

Model Number	2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-mar-2026, it was reported by a sales representative via email that an ar-7523 mini suture tape meniscus repair needle would not advance past the curve of an ar-7900 zonenavigator system handle.The issue was discovered during a meniscal repair procedure performed on (b)(6) 2026.No additional details were provided.Additional information was received on 25-mar-2026: when the ar-7900 zonenavigator system handle failed, the cannula was replaced with an ar-7905 zone navigator system cannula; however, the needle still could not be passed.Therefore, the case was completed using other product by converting to an outside-in approach.The procedure was delayed by approximately five to ten minutes as multiple methods were attempted to pass the needle through the cannula.No additional anesthesia was believed to have been administered to the patient.Additional information was received on 01-apr-2026: the patient did not experience a temporary impairment or significant increase in recovery time as a result of switching to an outside approach.An incision was already present for dealing with the hardware portion of the tibia plateau fracture.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: 2-0 SUTURETAPE 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: jared engle ; 8009337001
• MDR Report Key: 24858871
• Report Number: 1220246-2026-02172
• Device Sequence Number: 13399101
• Product Code: GAT
• UDI-Device Identifier: 00888867298002
• UDI-Public: (01)00888867298002(11)240501(17)290430(10)4079139663
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K221354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2026

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: 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
• Device Catalogue Number: AR-7523
• Device Lot Number: 4079139663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2024
• 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