MAUDE Adverse Event Report: ARTHREX, INC. 90 DEG CURVE STRAIGHT, QUICKPASS LASSO; ORTHOPEDIC MANUAL SURG INSTR

Model Number	90 DEG CURVE STRAIGHT, QUICKPASS LASSO
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 03/11/2025, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6068-90 90° curve straight broke when the tip was inserted into the rotator cuff.The case was completed by using another of the same product.This was discovered during a rotator cuff repair procedure on (b)(6)2025, with no reported patient harm.Additional information was received on 03/19/2025: there was no case delay or added anesthesia administered to the patient.All fragments were retrieved from the patient.This occurred on first use of the device.
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 prying/leveraging the device during use.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Upon visual inspection, the tip of the 90° curve straight, quickpass lasso was broken off.Functional testing was not performed due to the damage to the device.The most likely cause of the reported failure can be attributed to user error of the device due to improper surgical technique, excessive mechanical forces, misaligned insertion, and/or prying/leveraging during use.

• Brand Name: 90 DEG CURVE STRAIGHT, 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: 21664028
• Report Number: 1220246-2025-01107
• Device Sequence Number: 20721363
• Product Code: LXH
• UDI-Device Identifier: 00888867038943
• UDI-Public: (01)00888867038943(11)240801(17)290731(10)4185150735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2025

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: 90 DEG CURVE STRAIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90
• Device Lot Number: 4185150735
• 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; 11/07/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 09/08/2025; 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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