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	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/13/2025, a sales representative reported via (b)(4) that an ar-6068-25tr 25-degree tight right-curved quickpass lasso plastic casing around the nitinol wire frayed intraoperatively, making it unusable during a labral repair.They opened a new ar-6068-25tr suturelasso to complete the case.There was no harm done to the patient, nor was there any significant procedural delay.
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.Based on the information provided, which may include the returned device (if available), photographs, videos, the event description, and any additional field input, arthrex has determined the most likely cause.The most likely cause is attributed to user-related factors such as the application of excessive force, passing the lasso through sharp or irregular bony edges, and prying or leveraging the device through tight spaces.

• 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: 23705777
• Report Number: 1220246-2025-05352
• Device Sequence Number: 21489935
• Product Code: LXH
• UDI-Device Identifier: 00888867038905
• UDI-Public: (01)00888867038905(11)250201(17)300131(10)5036156712
• 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): 03/17/2026

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: 5036156712
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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