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	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the passing wire was used to pass the suture of a knotless suturetak, the passing wire itself was severely frayed and would not engage in the ar-6068-90l lasso so the wire could not be retracted or pushed out.A second lasso of the same lot was opened for the next anchor and the same exact problem occurred.The rep reported nothing broke off inside the patient.The case was finished by using a birdbeak for suture passing on the final anchor.The rep stated it looked as if something in the lasso was fraying the passing wire as it was being pushed out both times.See source data attached.
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.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, the complaint allegation is not confirmed without the device being returned or any photos 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.

• 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: 19515394
• Report Number: 1220246-2024-05589
• Device Sequence Number: 14329093
• Product Code: LXH
• UDI-Device Identifier: 00888867038950
• UDI-Public: 00888867038950
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 06/11/2024

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: 0330108217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/11/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown