MAUDE Adverse Event Report: ARTHREX, INC. REELPASS SUTR LASSO,90° CRV STR; ORTHOPEDIC MANUAL SURG INSTR

Model Number	REELPASS SUTR LASSO,90° CRV STR
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
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 02/25/2025, it was reported by a facility representative via (b)(4) that an ar-6069-90 reelpass suture lasso was fed through a little bit of monofilament but then stopped.The device was removed and monofilament manually pulled out of the passer.The passer was then tested with the wheels but would not expel any monofilament.The procedure was completed successfully by opening up a new device.This occurred during a labral repair with no patient impact.
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 can be attributed misuse due to incorrect surgical technique.

• Brand Name: REELPASS SUTR LASSO,90° CRV STR
• 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: 21584758
• Report Number: 1220246-2025-00893
• Device Sequence Number: 9276177
• Product Code: LXH
• UDI-Device Identifier: 00888867115934
• UDI-Public: (01)00888867115934(11)210913(17)251130(10)12214999
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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: 11/30/2025
• Device Model Number: REELPASS SUTR LASSO,90° CRV STR
• Device Catalogue Number: AR-6069-90
• Device Lot Number: 12214999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2021
• 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