MAUDE Adverse Event Report: ARTHREX, INC. 25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/03/2025, a facility representative reported via (b)(4) that an ar-6068-25tl 25-degree tight left-curved quickpass lasso was being used to pass through the labrum.After passing through, there was scraping.The device was taken out and inspected.When it went back in, it snapped.Part of the item was removed, but the tip remained inside the patient's capsule.The broken piece took over two hours to retrieve from the patient, who seems to be normal as of now.
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 for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: 25 DEG TIGHT CURVE LEFT, 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: 23887388
• Report Number: 1220246-2025-05789
• Device Sequence Number: 9605445
• Product Code: LXH
• UDI-Device Identifier: 00888867038899
• UDI-Public: (01)00888867038899(11)250501(17)300430(10)5126159723
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 25 DEG TIGHT CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-25TL
• Device Lot Number: 5126159723
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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