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 Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
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 12/01/2025, a distributor reported via (b)(4) that an ar-6068-45r 45-degree right-curved quickpass lasso bent upon passing the labrum during a bankart procedure, which was completed successfully with no patient harm.
Additional Manufacturer Narrative
Additional information: g3, h3, h6, the complaint device was not received for evaluation.Based on the provided information, including the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is user error.This includes misaligned insertion and/or prying or levering the device during insertion, which can result in device damage.Since the complaint device was not returned, and no evidence of the failure was provided.

• 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: 23863098
• Report Number: 1220246-2025-05745
• Device Sequence Number: 9295033
• Product Code: LXH
• UDI-Device Identifier: 00888867038936
• UDI-Public: (01)00888867038936(11)250101(17)291231(10)4355155457
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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 RIGHT, FASTPASS LASSO
• Device Catalogue Number: AR-6068-45R
• Device Lot Number: 4355155457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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