MAUDE Adverse Event Report: ARTHREX, INC. SUTURE LASSO, PIGTAIL, LEFT CURVED; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURE LASSO, PIGTAIL, LEFT CURVED
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 26 april 2024, it was reported by warehouse via email that for an ar-8690sll suture lasso, pigtail, left curved the surgeon was unable to pass the wire loop through the pigtail lasso.This occurred during a plantar plate repair in southern cross hospital, christchurch.The case was completed successfully via the use of another suture lasso.There was case involvement.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used when attempting to advance the wire.

• Brand Name: SUTURE LASSO, PIGTAIL, LEFT CURVED
• 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: 19330778
• Report Number: 1220246-2024-03386
• Device Sequence Number: 6816222
• Product Code: LXH
• UDI-Device Identifier: 00888867198401
• UDI-Public: 00888867198401
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• 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): 05/21/2025

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: SUTURE LASSO, PIGTAIL, LEFT CURVED
• Device Catalogue Number: AR-8690SLL
• Device Lot Number: 14979065
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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