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

Model Number	90 DEG CURVE RIGHT, QUICKPASS LASSO
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2024
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 19 september 2024, it was reported by a sales representative via email that an ar-6068-90r 90 deg curve right, quickpass lasso was reported to not function correctly during a case.This occurred on (b)(6) 2024 in (b)(6) hospital during an unknown procedure.It was reported that the 90 degree quickpass lasso was opened and the scrub nurse checked the wire loop was advancing, the surgeon put the lasso through the labral tissue and then could not get the wire loop to advance.Trouble shooting was performed to ascertain whether tissue was blocking the tip of which it was not.The wire loop then proceeded to come out of the device at the roller wheel.Another quickpass lasso (25 degree) was then opened.When the surgeon fed the loop out of the lasso it would not advance past the end of the loop.The surgeon was using a single portal technique so it was not possible to grasp the loop with a grasper which would have released the resistance of the wire loop to advance.The case was completed successfully.The wire loop from the lasso was inserted backwards and retrieved using a grasper and then the suture was shuttled through the labrum.There was case involvement.
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: 90 DEG 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: 20416306
• Report Number: 1220246-2024-08062
• Device Sequence Number: 8221719
• Product Code: LXH
• UDI-Device Identifier: 00888867038967
• UDI-Public: (01)00888867038967(11)201201(17)251130(10)0330108216
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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 Expiration Date: 11/30/2025
• Device Model Number: 90 DEG CURVE RIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90R
• Device Lot Number: 0330108216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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