MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
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 (b)(6) 2024, a sales representative via sems-06665104 reported that an ar-4068-25tl suturelasso sd loop was broken/not complete when inserted into the patient.This occurred when the surgeon passed the tip of the suturelasso and then thumbed the nitinol wire forward to expose the loop.Once the loop was exposed, the issue was noticed.The surgeon had not touched it with an instrument yet, which was reported defective from the start.They opened an additional suturelasso and proceeded as normal to complete the case.There was no extra time added or harm to the patient.This was discovered during a labral repair procedure on (b)(6) 2024.Additional information was received on 09/19/2024: the broken/incomplete ar-4068-25tl suturelasso sd loop was removed entirely from the patient.
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 user error of the device due to applying excessive mechanical forces and/or prying/leveraging the device during use.

• Brand Name: SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
• 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: 20460307
• Report Number: 1220246-2024-08138
• Device Sequence Number: 8773593
• Product Code: LXH
• UDI-Device Identifier: 00888867031425
• UDI-Public: (01)00888867031425(11)210401(17)260331(10)1095111334
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/07/2025

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 Expiration Date: 03/31/2026
• Device Model Number: SUTURELASSO, 25 DEGREE TIGHT CURVE LEFT
• Device Catalogue Number: AR-4068-25TL
• Device Lot Number: 1095111334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2021
• 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