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

Model Number	MENISCAL CINCH
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 8/17/2023, it was reported by an arthrex employee via e-mail that an ar-4500 meniscal cinch could not deploy the second anchor; the anchor did not come loose from the needle.Due to device failure, the surgeon completed the procedure as a meniscectomy on (b)(6) 2023.Additional information received on 8/18/2023: two ar-45700 meniscal cinch failed during this procedure.The first meniscal cinch could not deploy the second anchor; it got stuck in the needle.The surgeon was able to remove the first anchor.A second meniscal cinch was opened, and the same happened; the second anchor could not be deployed as it got stuck in the needle.The surgeon used a scorpion needle to finish the stitch with the remaining suture from the meniscal cinch.The first anchor remains in the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Since the complaint device was not returned, a physical evaluation of the device was not performed.Without the device being returned or any photos provided, the reported event is not confirmed.The most likely cause for the reported failure can be attributed to user error due to excessive movement of the device between deploying implant #1 and implant #2 can disrupt the deployment mechanism.

• 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: 19524300
• Report Number: 1220246-2024-05643
• Device Sequence Number: 20895886
• Product Code: GAT
• UDI-Device Identifier: 00888867033535
• UDI-Public: 00888867033535
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MENISCAL CINCH
• Device Catalogue Number: AR-4500
• Device Lot Number: 15080417
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown