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	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2022
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.Complaint is confirmed.Upon visual evaluation, the suture wire stuck between the device's wheels.Functional testing found that the device does not function as required.The most likely cause of this condition is excessive force/friction during use or insertion.
Event or Problem Description
It was reported that during a shoulder stabilization surgery the suture passing wire did not pass through the device.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device from another manufacturer.It was not necessary to do a second surgery.Update swit 09-jan-2022: a pds-suture was used to finish the surgery successfully, it´s a device from a different manufacturer.

• 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: 19360009
• Report Number: 1220246-2024-03592
• Device Sequence Number: 17746390
• Product Code: LXH
• UDI-Device Identifier: 00888867038950
• UDI-Public: 00888867038950
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2024

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: 07/31/2026
• Device Model Number: 90 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90L
• Device Lot Number: 1201114140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown