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

Model Number	PASSPORT BUTTON CANNULA
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 05/29/2025, a representative reported via sems-06905162 that (2) ar-6592-08-30 arthrex® passport button cannulas and an ar-6592-12-30 arthrex® passport button cannula ripped upon first insertion.There was no additional information provided, and additional information has been requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misaligned insertion, and/or applying excessive mechanical forces upon insertion of mating part.

• 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: 22306676
• Report Number: 1220246-2025-02617
• Device Sequence Number: 8586580
• Product Code: MDM
• UDI-Device Identifier: 00888867040595
• UDI-Public: (01)00888867040595(11)240514(17)290430(10)15248422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2025

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-6592-08-30
• Device Lot Number: 15248422
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown