MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 45 DEGREE CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 45 DEGREE CURVE RIGHT
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
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 3rd april 2025, it was reported by a sales representative via email that for an ar-4068-45r, suturelasso, 45 degree curve right, the suture lasso metal tip was blunt and could not penetrate the labral tissue.This was detected during use in an arthroscopic shoulder stabilisation procedure on (b)(6) 2025.The procedure was completed successfully as a new suture lasso was opened.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTURELASSO, 45 DEGREE CURVE RIGHT
• 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: 21864262
• Report Number: 1220246-2025-01546
• Device Sequence Number: 4684756
• Product Code: LXH
• UDI-Device Identifier: 00888867031494
• UDI-Public: (01)00888867031494(11)250101(17)291231(10)4318154583
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: SUTURELASSO, 45 DEGREE CURVE RIGHT
• Device Catalogue Number: AR-4068-45R
• Device Lot Number: 4318154583
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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