MAUDE Adverse Event Report: ARTHREX, INC. ROTATION LASSO, 90 DEG TIP; ORTHOPEDIC MANUAL SURG INSTR

Model Number	ROTATION LASSO, 90 DEG TIP
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 23-dec-2025, a sales representative reported via phone that an ar-6065-90 rotation lasso, 90° experienced an issue during a procedure on(b)(6) 2025.The white knob did not rotate as intended while the device was in use inside the patient.All components were successfully removed, and the procedure was completed using an alternate product without delay.No patient harm was reported.
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.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a use error, including obstruction on the cannulation, preventing the device's proper function and/or surgical technique associated with the device.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: ROTATION LASSO, 90 DEG TIP
• 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: 24039348
• Report Number: 1220246-2026-00162
• Device Sequence Number: 13359095
• Product Code: LXH
• UDI-Device Identifier: 00888867288652
• UDI-Public: (01)00888867288652(11)250801(17)300731(10)5202170786
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/28/2026

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: ROTATION LASSO, 90 DEG TIP
• Device Catalogue Number: AR-6065-90
• Device Lot Number: 5202170786
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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