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

Model Number	90 DEG TIGHT CURVE QUICKPASS LASSO
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder instability repair it was found that the curvature of the quickpass suture lasso is too much curved.It was further reported that due to this failure it is not possible to pass through a portal with an inner diameter of 7mm.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
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 confirmed.One unpackaged ar-6068-90t was received for investigation.Dimensional analysis conducted with micro-vu id: 654 identified that the tip length of the returned ar-6068-90t was out of tolerance.Confirmation was received from vendor phoenix medical that the ar-6068-90t, batch 0154104154 was manufactured prior to corrective action for this failure mode.The complaint batch falls within scope of ncr-14916 for this issue.

• Brand Name: 90 DEG TIGHT CURVE 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: 19213356
• Report Number: 1220246-2024-02622
• Device Sequence Number: 8105318
• Product Code: LXH
• UDI-Device Identifier: 00888867038974
• UDI-Public: 00888867038974
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 04/30/2024

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: 05/31/2025
• Device Model Number: 90 DEG TIGHT CURVE QUICKPASS LASSO
• Device Catalogue Number: AR-6068-90T
• Device Lot Number: 0154104154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown