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	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 04-feb -2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6068-90 lasso tip broke off.This occurred during use in a case with no patient effect.No excessive force was applied, and the device was used normally.A new product was opened and the procedure was completed.There were no health risks to the patient, such as the device remaining inside the body.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 one unpackaged ar-6068-90, batch 5231171753, was received for investigation.Visual inspection revealed that the device was returned with a fractured tip.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to off-axis loading or prying and leveraging the device.The complaint allegation is confirmed.Refer to the investigation photos.

• 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: 24414437
• Report Number: 1220246-2026-00865
• Device Sequence Number: 12246988
• Product Code: LXH
• UDI-Device Identifier: 00888867038943
• UDI-Public: (01)00888867038943(11)250901(17)300831(10)5231171753
• 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): 06/03/2026

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: 5231171753
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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