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

Model Number	MENISCAL CINCH
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
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 2nd april 2025, it was reported by an arthrex employee via email that for an ar-4500, meniscal cinch, the anchor was pulled out.This was detected during a meniscus repair procedure on (b)(6) 2025.The procedure was completed successfully by using another new ar-4500.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.One unpacked ar-4500, meniscal cinch, batch 15116180, was received for evaluation.- upon visual inspection, it was noted that the device arrived for evaluation with trocar #1 and #2, as well as the detached sutures and implant.Trocar 1 and 2 were bent and therefore, functional testing was not performed due to the damage to the device.- the most likely cause is attributed to misuse due to prying/leveraging the device during use.- the complaint allegation is confirmed.- refer to the investigation photos.

• 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: 21859574
• Report Number: 1220246-2025-01532
• Device Sequence Number: 7916855
• 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): 08/28/2025

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: 04/02/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/28/2025
• 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