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

Model Number	25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
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
On 11/24/2025, a sales representative reported that an ar-6068-25tr 25°, tight curve, right, quickpass lasso experienced an issue during a labral repair procedure on (b)(6) 2025.The plastic casing around the nitinol wire frayed intraoperatively inside the patient, with the plastic casing around the nitinol wire delaminated, rendering the device unusable.The broken fragment was retrieved, and there was no patient harm or significant procedural delay.Additional observations included that the lasso wheel felt rough out of the box.The case was completed using a replacement ar-6068-25tr device.No details regarding bone preparation or bone quality were documented.Additional information was received on 11/26/2025: the ar-6068-25tr 25°, tight curve, right, quickpass lasso device exhibited fraying and delamination of the plastic casing around the nitinol wire on first use while being deployed through the labral tissue.The surgeon noted that the wheels felt rough prior to insertion.No surgical delay or additional anesthesia occurred, as a second device was available and used.No photos or videos of the complaint device were provided.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided ¿ which may include the returned device (if available), photographs, videos, event description, and any additional field input ¿ arthrex has determined the most likely cause.The most likely cause is increased friction in the internal wheel mechanism from excessive force, leading to abrasion of the casing.

• Brand Name: 25 DEG TIGHT CURVE RIGHT 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: 23770278
• Report Number: 1220246-2025-05557
• Device Sequence Number: 10615475
• Product Code: LXH
• UDI-Device Identifier: 00888867038905
• UDI-Public: (01)00888867038905(11)250101(17)291231(10)4354155422
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 RIGHT QUICKPASS LASSO
• Device Catalogue Number: AR-6068-25TR
• Device Lot Number: 4354155422
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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