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

Model Number	45 DEG CURVE RIGHT, FASTPASS LASSO
Medical Device Problem Codes	Material Frayed (1262); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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 12/10/2024, a sales representative via (b)(4) reported that an ar-6068-45r 45°, curve, right, quickpass lasso had an issue.The surgeon could not turn the wheel and advance the wire as though it was stuck.No damage or harm was caused to the patient.No case delay was reported, an additional lasso was used, and the case proceeded as normal.This was discovered during a labral repair procedure on (b)(6) 2024, with no reported patient harm.Per the rep, upon examination of the defective lasso, "after the case was over, we had the tech examine the defective lasso on the back table and it looked like the wire was frayed inside of the lasso handle itself which was what prevented the wheel from turning." additional information was received on 12/14/2024: this was not a reload but on the device's first use.The device is not available for return as they took it apart on the back table and then disposed of it.
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 excessive force being used when engaging the wheel.

• Brand Name: 45 DEG CURVE RIGHT, FASTPASS 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: 21084773
• Report Number: 1220246-2025-09230
• Device Sequence Number: 6773665
• Product Code: LXH
• UDI-Device Identifier: 00888867038936
• UDI-Public: (01)00888867038936(11)231101(17)281031(10)3261134990
• 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): 07/11/2025

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: 45 DEG CURVE RIGHT, FASTPASS LASSO
• Device Catalogue Number: AR-6068-45R
• Device Lot Number: 3261134990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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