MAUDE Adverse Event Report: ARTHREX, INC. PASSPORT BUTTON CANNULA; MANUAL INSTR, GENERAL SURGICAL

Model Number	PASSPORT BUTTON CANNULA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
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 allegation is confirmed.Two unpackaged ar-6592-06-30, batch number 14921193, were received for investigation.Visual evaluation found that the two returned cannulas had a piece of the flange torn.The most likely cause of the reported failure is user error, which can be attributed to excessive mechanical forces and/or mishandling.
Event or Problem Description
It was reported on 07/29/2022 by a arthrex employee via (b)(4) that an ar-6592-06-30 passport cannula has torn fins.This was discovered during a case with no patient harm.

• Brand Name: PASSPORT BUTTON CANNULA
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19472737
• Report Number: 1220246-2024-05003
• Device Sequence Number: 7441379
• Product Code: MDM
• UDI-Device Identifier: 00888867040557
• UDI-Public: 00888867040557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: 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: PASSPORT BUTTON CANNULA
• Device Catalogue Number: AR-6592-06-30
• Device Lot Number: 14921193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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