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

Model Number	90 DEG CURVE LEFT, QUICKPASS LASSO
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
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 complaint device was not received for evaluation.Based off the information provided, 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.
Event or Problem Description
On 02/10/2023, it was reported by a sales representative via (b)(4) that (14) ar-6068-90l quickpass lassos, (9) ar-6068-90r quickpass lassos wire inside of the passers or coverture are not allowing the lassos to pass through.This occurred during a case.Additional information provided 2/15/2023: per the sales representative the procedure performed was a shoulder arthroscopy.The issue is that the wire is not able to facilitate all the way down.The case was completed by using a new ar-6068-90l from a different batch, lot number not available.(qty.14) ar-6068-90l quickpass lassos, (qty.9) ar-6068-90r quickpass lassos will be returned but were not all used in this particular case but has had the same issue in other cases, with no additional information available.

• Brand Name: 90 DEG CURVE LEFT, 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: 19520650
• Report Number: 1220246-2024-05619
• Device Sequence Number: 12304918
• Product Code: LXH
• UDI-Device Identifier: 00888867038950
• UDI-Public: 00888867038950
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 06/12/2024

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 Model Number: 90 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90L
• Device Lot Number: 228412607
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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