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

Model Number	MENISCAL CINCH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation and therefore the alleged complaint event could not be confirmed.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when tensioning the sutures.
Event or Problem Description
It was reported that during a surgery when the surgeon implanted the back stop number one and two and started for tension the fiber wire, the back stop pulled out.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update swit 06-jul-2022: another cinch was used and they fixed the minscuses successfully.

• 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: 19280856
• Report Number: 1220246-2024-03054
• Device Sequence Number: 6338746
• Product Code: GAT
• UDI-Device Identifier: 00888867033535
• UDI-Public: 00888867033535
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K073149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 14955516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2022
• 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