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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 9/30/2021, it was reported by a sales representative via sems that an ar-6068-90r quickpass lasso, qty.2 of the passing wire would not deploy from the device making the product unusable.This was discovered during use in a right shoulder arthroscopy with anterior labral repair on (b)(6) 2021.The case was completed by using a third ar-6068-25tr.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to user error due to chamber plate improperly attached to the centrifuge adapter.As no further investigation was able to be performed no change in harm was identified.

• 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: 19398869
• Report Number: 1220246-2024-03967
• Device Sequence Number: 7800224
• Product Code: LXH
• UDI-Device Identifier: 00888867038967
• UDI-Public: 00888867038967
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 05/26/2024

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: 06/30/2026
• Device Model Number: 90 DEG CURVE RIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90R
• Device Lot Number: 1176113517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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