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	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
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.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing.
Event or Problem Description
On 04/27/2022, it was reported by a sales representative via sems that an ar-6068-90r 90°, curve, right, quickpass lasso, and an ar-6068-90l 90°, curve, left, quickpass lasso had an issue.The surgeon was performing a shoulder labral repair on 04/25/2022 in the lateral decubitus position.As they began to repair the labrum, he introduced the 90 degree right quickpass lasso into the joint, through the capsule, and around the torn labrum.He was careful not to scrape the glenoid excessively in case bone were to get stuck in the passer.He then tried rolling the wheels to expel the nitinol wire but it would not come out of the tip.The passer was removed from the joint and examined, finding nothing wrong with the device other than the fact it would not pass the wire.It was reintroduced and passed around the labrum but the issue persisted.The pass was made successfully by opening up a conmed spectrum.Later in the case, the surgeon asked for a 90 degree left quickpass lasso.The device was opened and tested before entering it into the joint, but the nitinol again did not expel.Again, the pass was made successfully by using a conmed spectrum.This was discovered during use with no impact to the patient.On 05/05/2022, the sales representative stated the following information via phone: nothing broke inside the patient, both complaint devices just did not expel.This was an out of box failure for both devices.

• 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: 19472687
• Report Number: 1220246-2024-05000
• Device Sequence Number: 20688924
• Product Code: LXH
• UDI-Device Identifier: 00888867038967
• UDI-Public: 00888867038967
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 06/05/2024

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 RIGHT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90R
• Device Lot Number: 1291116516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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