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

Model Number	MENISCAL CINCH
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
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 29 april 2025, it was reported by an arthrex employee via email that for a total of 4 units of ar-4500, meniscal cinch, both implants failed to set.This was detected during an right knee meniscus repair surgery on (b)(6) 2025.The procedure was completed successfully with a total use of 8 units of ar-4500; 4 succeeded and 4 failed.There was no patient harm, and no secondary procedure needed.The knot pusher/cutter type is ar-4515.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpackaged ar-4500 meniscal cinch batch 15116180 was received for evaluation.Visual inspection revealed that both insertion spears were on the cannula.The depth stop was between the 10 and 14 marks, with both insertion spears' handles far backward and together.The evaluation of the suture found fraying on the tails with missing anchors.Functional testing was attempted by moving/sliding the insertion spears, both of which were removed from the shaft and inspected.No bent or other issues were noted.The most likely cause of the reported and observed failure is user error, specifically improper surgical technique using the device.Directions for use (dfu) dfu-0156-6 all-inside meniscal repair devices.E.Warnings 7.Pre-operative and operating procedures, including knowledge of surgical techniques and proper selection and placement of the device, are important considerations in the successful utilization of this device.The appropriate arthrex delivery system is required for proper implantation of the device.G.Precautions 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.7.In the event of unsuccessful implantation, the device(s) should only be retrieved under visual confirmation and if loose.Any attempt at retrieving devices entrapped in tissue or without visual confirmation of location may result in tissue damage or injury to the patient.8.Speedcinch, 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.11.Meniscal cinch device only: to avoid premature tension to construct do not pull external suture before releasing trocar #2.12.Meniscal cinch and softstitch devices only: do not trap external suture against handle.13.Meniscal cinch device only: after implanting #1, do not move device before releasing trocar #2.14.Softstitch device only: keep the pushrod in the implant delivery cannula when penetrating soft tissue.

• Brand Name: MENISCAL CINCH
• 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: 22035486
• Report Number: 1220246-2025-02070
• Device Sequence Number: 12925614
• Product Code: GAT
• UDI-Device Identifier: 00888867033535
• UDI-Public: (01)00888867033535(11)230713(17)280630(10)15116180
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K073149
• 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): 07/09/2025

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
• Device Catalogue Number: AR-4500
• Device Lot Number: 15116180
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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