MAUDE Adverse Event Report: ARTHREX, INC. MENISCAL CINCH¿ II; POLYETHYLENE SYNTHETIC SUTURE

Model Number	MENISCAL CINCH¿ II
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 3rd nov 2025, it was reported by an arthrex's employee via an email that for 1 unit of ar-4501, meniscal cinch¿ ii, the first implant was set properly but when triggered the second implant, the button was stuck.This was detected during an anterior cruciate ligament reconstruction and meniscus injury procedure.The procedure was completed successfully by using another new ar-4501.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 for the reported failure can be attributed to misuse/mishandling due to improper functioning of the device by the user.

• Brand Name: MENISCAL CINCH¿ II
• 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: 23618252
• Report Number: 1220246-2025-05132
• Device Sequence Number: 21095249
• Product Code: GAT
• UDI-Device Identifier: 00888867299139
• UDI-Public: (01)00888867299139(11)240422(17)290331(10)15237698
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132043
• 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): 03/09/2026

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: MENISCAL CINCH¿ II
• Device Catalogue Number: AR-4501
• Device Lot Number: 15237698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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