MAUDE Adverse Event Report: ARTHREX, INC. 45 DEG CURVE LEFT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	45 DEG CURVE LEFT, QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/26/2025, it was reported by a facility representative via sems-(b)(4) that an ar-6068-45l 45 deg curve left quickpass lasso had a portion of the device break off.This was discovered during a labral repair with no patient harm.
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.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 of the reported failure can be attributed to misuse/mishandling due to damage to the device, misaligned insertion/ prying/leveraging the device during insertion.Dfu-0222-eo.2.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.

• Brand Name: 45 DEG CURVE LEFT, 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: 23064062
• Report Number: 1220246-2025-03884
• Device Sequence Number: 13228143
• Product Code: LXH
• UDI-Device Identifier: 00888867038929
• UDI-Public: (01)00888867038929(11)250201(17)300131(10)5036156710
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2026

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: 45 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-45L
• Device Lot Number: 5036156710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2025
• 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