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	03/07/2022
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 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 of the device due to excessive force used during suture passing/tightening /tensioning.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 03/07/2022, it was reported by a sales representative via sems that qty.2 of an ar-6068-90l 90°, curve, left, quickpass lasso had an issue.The surgeon was performing a posterior labral repair of a right shoulder on (b)(6) 2022.A 90 curve left quickpass lasso was opened to pass sutures in the 6 o'clock position.Out of the package, the scrub tech tried to expel the nitinol guide wire, but it would not come out the tip.The scrub tech then took the nitinol guide wire out of the passer and tried to load the passer again, but again it would not expel out of the tip.After numerous attempts, a second 90 degree curve left quickpass lasso was opened.This lasso had a small amount of nitinol guide wire hanging out the tip, so this was pulled through the tip completely and tried to reload it but the passer once again did not expel the suture.The case was completed successfully by using a conmed spectrum.This was discovered during the unboxing of the complaint device with no case/patient involvement.

• 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: 19385260
• Report Number: 1220246-2024-03765
• Device Sequence Number: 6913994
• Product Code: LXH
• UDI-Device Identifier: 00888867038950
• UDI-Public: 00888867038950
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 09/30/2026
• Device Model Number: 90 DEG CURVE LEFT, QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90L
• Device Lot Number: 1274116122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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