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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
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 23-feb -2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6068-90 lasso loop broke when it was turned with too much force.This occurred during use in a case with no patient effect.

• 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: 24617147
• Report Number: 1220246-2026-01449
• Device Sequence Number: 21290448
• Product Code: LXH
• UDI-Device Identifier: 00888867038943
• UDI-Public: 00888867038943
• 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
• Report Date (Section B): 07/13/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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