MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO 25° RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO 25° RIGHT
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
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.The complaint is confirmed.One unpackaged ar-6068-25r was received for investigation.The returned device was visually inspected and noted that the suture was attached to the handle.The returned device was tested and evaluated under normal use conditions to see if the issue(s) reported could be reproduced.The functional test found resistance when the wheels were trying to move.After removing the suture, the wheels rotate freely.The most likely cause for the reported failure is user error for applying excessive force during use.
Event or Problem Description
It was reported that during sewing the meniscus the suture inside the lasso could not be released because it was caught on the wheel.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.

• Brand Name: SUTURELASSO 25° RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19398848
• Report Number: 1220246-2024-03954
• Device Sequence Number: 7799747
• Product Code: GAT
• UDI-Device Identifier: 00888867247512
• UDI-Public: 00888867247512
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/26/2024

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: 02/28/2025
• Device Model Number: SUTURELASSO 25° RIGHT
• Device Catalogue Number: AR-6068-25R
• Device Lot Number: 0059101692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 05/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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