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

Model Number	90 DEG CURVE STRAIGHT, QUICKPASS LASSO
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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 10/22/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6068-90 quickpass lasso wire loop began to come out from the roller at the handle midway through the procedure.Because the hospital is familiar with this product, we tried various methods, including reloading and inserting it from the tip, but it would not come out properly from the tip, and the procedure was interrupted.The user opened a new product and proceeded with the procedure, which was successfully completed.This occurred during use in a meniscus centralization case with no patient effect.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-6068-90, batch 5044157010, was received for investigation.Visual inspection found no abnormalities or damage to the exterior of the device.Functional testing verified that the actuation wheel advanced and retracted the nitinol component as intended.No problem found.The complaint allegation is not confirmed.Refer to the investigation photos.
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 additional field input, arthrex has determined the most likely cause of the reported issue.The most likely cause is attributed to use-related factors, specifically improper surgical technique such as misrouting of the lasso loop, leading to kinking and bunching within the handle.

• Brand Name: 90 DEG CURVE STRAIGHT, 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: 23434673
• Report Number: 1220246-2025-04918
• Device Sequence Number: 4733344
• Product Code: LXH
• UDI-Device Identifier: 00888867038943
• UDI-Public: (01)00888867038943(11)250301(17)300228(10)5044157010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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: 90 DEG CURVE STRAIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90
• Device Lot Number: 5044157010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 02/23/2026; 03/13/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 02/25/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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