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

Model Number	MENISCAL CINCH¿ II
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 4th august 2025, it was reported by an arthrex's employee via email that for 1 unit of ar-4501, meniscal cinch¿ ii, both implants were deploy and set properly, when retrieving the suture, it broke, and both implants was pulled out.This was detected during a meniscus repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-4501.There was 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
Additional information: d9, g3, h3, h6.Complaint allegation is not confirmed.Upon visual evaluation, it was noted that the suture returned was frayed and no one of the two implants was returned.One of the trigger buttons was damaged.The most likely cause is attributed to misuse due to user error of using excessive force to pry, leverage the device, and/or due to improper surgical technique.

• 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: 22854564
• Report Number: 1220246-2025-03567
• Device Sequence Number: 4350279
• Product Code: GAT
• UDI-Device Identifier: 00888867299139
• UDI-Public: (01)00888867299139(11)240617(17)290531(10)15274474
• 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): 12/05/2025

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: MENISCAL CINCH¿ II
• Device Catalogue Number: AR-4501
• Device Lot Number: 15274474
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown