MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG TIGHT CURVE QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	90 DEG TIGHT CURVE QUICKPASS LASSO
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder instability surgery it was difficult to deliver the suture with the lasso.2 products with the same batch/lot (ar-6068-90t/4247152361) were tried.No part of the devices broke off.Per complaint reporter 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged quickpass lasso, ar-6068-90t, batch 4247152361, was received for evaluation.Visual inspection noted no issues with the device.Functional testing was performed by using the thumbwheel to retract and deploy the nitinol loop; the device functioned as intended.No problems were identified during evaluation.The complaint allegation is not confirmed.Refer to the attached investigation photos.

• Brand Name: 90 DEG TIGHT CURVE QUICKPASS LASSO
• 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: 23541693
• Report Number: 1220246-2025-05058
• Device Sequence Number: 13205364
• Product Code: LXH
• UDI-Device Identifier: 00888867038974
• UDI-Public: (01)00888867038974(11)240901(17)290831(10)4247152361
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 12/30/2025

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: 90 DEG TIGHT CURVE QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90T
• Device Lot Number: 4247152361
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown