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

Model Number	MENISCAL CINCH¿ II
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 27th 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 however the second implant was broken.This was detected during a meniscus repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-4501.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-4501 meniscal cinch ii, batch 15255251, was received for investigation.Visual inspection revealed that the suture was at the cannula tip and showed broken filaments.It was noted that the anchor is not present.An attempt was made to remove the suture from the shaft to visually evaluate, but it was found to be stuck inside the cannula.It was noted that the pushrod inside the molded handle was bent, damaging the handle's internal deployment system.Upon taking the depth stop out of the cannulated shaft, it was noted that there was no bend or other damage to the shaft.A functional test was not performed because the device was severely damaged.The most likely cause of the reported and observed device failure is user error, including the application of excessive side-loaded force, prying or levering of the device, incorrect surgical technique, and excessive manual force during deployment.Directions for use dfu-0156-eo at revision 1.Suture retention devices.G.Precautions: 1.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or contact your arthrex representative for an onsite demonstration.3.The depth stop should be used to avoid piercing structures peripheral to the capsule.4.Particular attention should be paid to excessive manually applied forces when deploying the device to avoid over-deployment.5.Do not bend the device cannula.6.Excessive movement of the device between deploying implant #1 and implant #2 can disrupt the deployment mechanism.8.Meniscal cinch ii and softstitch devices only: do not advance the implant beyond the tip of the cannula before penetrating the meniscus.9.Meniscal cinch device only: do not pull the trocar back into the cannula after it has been advanced as this could prematurely deploy the implant.10.Meniscal cinch device only: if resistance is felt during implant deployment, advance trocar to depth stop and rotate trocars back and forth with controlled pressure.This is to avoid damaging implants.12.Meniscal cinch and softstitch devices only: do not trap external suture against handle.Meniscal cinch device only: to avoid premature tension to construct do not pull external suture before releasing trocar #2.According to the surgical technique.Meniscal cinch ii technique.4a.Advance the button completely to deploy the first implant.4b.Retract the button until it locks in place flush with the adjacent button.5.Advance the second implant into the needle tip by pushing the second button forward to the raised indicator.Note: rotating the needle slot away from the first implant and penetrating the meniscus can sever the suture.6a.Advance the needle through the meniscus by pushing the entire handpiece forward until the desired depth is reached.Advance the button past the indicator to the end point to deploy the second implant.6b.Retract the button until it locks in place flush with the adjacent button.

• 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: 23827716
• Report Number: 1220246-2025-05655
• Device Sequence Number: 5080328
• Product Code: GAT
• UDI-Device Identifier: 00888867299139
• UDI-Public: (01)00888867299139(11)240529(17)290430(10)15255251
• 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): 03/24/2026

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: 15255251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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