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	Insufficient Information (4580)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Upon visual evaluation, it was noted that both implants had been deployed.No problem found with the device.
Event or Problem Description
On 2/17/2022 it was reported by an arthrex employee via email that an ar-4500 meniscal cinch first anchor was deployed but when the second anchor was deployed, it could not be located.Surgeon opened a new meniscal cinch and the second anchor deployed was loose.To complete case, surgeon used a third meniscal cinch from different lot.No further issues were reported.This was discovered during a meniscal repair procedure on (b)(6) 2022.Additional information received 2/21/2022: while using the first ar-4500 meniscal cinch, the second anchor did not deploy and surgeon could not find the anchor when the tip was pushed.Surgeon cut out the sutures and removed the first anchor.A second ar-4500 meniscal cinch was opened and because the second anchor did not seat and was too loose, surgeon cut out the sutures and removed both anchors.Case was completed using a third meniscal cinch.

• 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: 19509833
• Report Number: 1220246-2024-05541
• Device Sequence Number: 19721381
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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 Expiration Date: 08/31/2026
• Device Model Number: MENISCAL CINCH
• Device Catalogue Number: AR-4500
• Device Lot Number: 14223734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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