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 Codes	Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11th march 2025, it was reported by a sales representative via email that for an ar-8690sll suturelasso¿, pigtail, left curved, the pigtail lasso wire would not pass / move freely through device.This occurred during use a plantar plate repair on (b)(6) 2025.The case was completed successfully as they opened a new pigtail lasso.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 of the reported failure can be attributed to user error, as the device was improperly inserted, and failed to push back/pushed forward the black lasso.

• 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: 21653551
• Report Number: 1220246-2025-01073
• Device Sequence Number: 9328679
• Product Code: LXH
• UDI-Device Identifier: 00888867198401
• UDI-Public: (01)00888867198401(11)240306(17)290228(10)15216761
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 15216761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown