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	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the anterior cruciate ligament surgery, the trigger mechanism did not click into place on the plastic and did not lock.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: MENISCAL CINCH¿ II
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• Manufacturer (Section D): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer (Section G): Arthrex, Inc.; 1370 creekside boulevard; naples FL 34108 -194
• Manufacturer Contact: jared engle ; +1(800)933-7001
• MDR Report Key: 50200868
• Report Number: 1220246-2026-04266
• Device Sequence Number: 5445602
• Product Code: GAT
• UDI-Device Identifier: 00888867299139
• UDI-Public: (01)00888867299139(11)260312(17)310228(10)15588440
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K132043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 15588440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown