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

Model Number	MENISCAL CINCH
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 1st july 2024, it was reported by an arthrex employee via email that for 2 units of ar-4500, meniscal cinch, the second implant set fell out before the button was pushed.The first implant set was properly placed but the second one fell out before the button was pushed.The surgeon used another ar-4500 to complete the procedure, but the same situation happened again.The case was completed successfully with another new ar-4500.This was discovered during a meniscus repair procedure on (b)(6) 2024.There was no patient harm and no secondary procedure was performed.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpacked ar-4500 meniscal cinch batch 14987863 was received for evaluation.Upon visual inspection, it was noted that the device arrived for evaluation with trocar #1 and #2 out of the delivery handpiece/handled.The trocar's functional setting within the shaft encountered no resistance.However, the testing occurred in the absence of implants.The most likely cause of the reported event is a user error following the device's surgical technique, per dfu-0156-6 at revision 0.G.Precautions.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.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.

• 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: 19827457
• Report Number: 1220246-2024-06897
• Device Sequence Number: 8891000
• Product Code: GAT
• UDI-Device Identifier: 00888867033535
• UDI-Public: 00888867033535
• 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): 09/27/2024

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: 14987863
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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