MAUDE Adverse Event Report: ARTHREX, INC. 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES; POLYETHYLENE SYNTHETIC SUTURE

Model Number	2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2023
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 complaint is confirmed based on the customer provided video, which displays the needles not passing through the cannula.As the device is not returning, the cause could not be determined.The most likely cause can be attributed to a blockage in the cannula due to a manufacturing issue or due to tissue getting stuck in the cannula during use.No change in harm was identified.
Event or Problem Description
It as reported that due to an acl + medial meniscus tear a repair of the meniscus by inside-out technique was planned with the zone navigator system.The surgeon was not able pass the meniscus repair needle through any of the zone navigator cannulas, while attempting the needles got damaged but did not pass through the cannula.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
• Common Device Name: POLYETHYLENE SYNTHETIC SUTURE
• 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: 19440176
• Report Number: 1220246-2024-04593
• Device Sequence Number: 8343249
• Product Code: GAT
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K221354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2024

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: 2-0 SUTURETAPE MENISCUS REPAIR NEEDLES
• Device Catalogue Number: AR-7523
• Device Lot Number: 2108121177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 05/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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