MAUDE Adverse Event Report: ARTHREX, INC. 25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
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 03/10/2025, it was reported by a sales representative via (b)(4) that an ar-6068-25tr 25°, tight curve, right, quickpass lasso had the head of the lasso snapped off while trying to pass around the labrum.The broken piece was retrieved from the patient.The case was completed successfully.This was discovered during a labral repair procedure on (b)(6)2025, with no reported patient harm.Additional information was received on 03/14/2025: there was a 15 minute delay to get the broken piece out of the shoulder.There was an extra 15 minutes of added anesthesia administered.The case was completed by opening another ar-6068-25tr.There was no report of negative effects on or after the surgery.
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: 25 DEG TIGHT CURVE RIGHT 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: 21664066
• Report Number: 1220246-2025-01108
• Device Sequence Number: 7554061
• Product Code: LXH
• UDI-Device Identifier: 00888867038905
• UDI-Public: (01)00888867038905(11)241101(17)291031(10)4291153738
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 25 DEG TIGHT CURVE RIGHT QUICKPASS LASSO
• Device Catalogue Number: AR-6068-25TR
• Device Lot Number: 4291153738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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