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	Foreign Body In Patient (2687)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 9/20/2023, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-6592-06-30 passport button cannula had an issue.The cannula insertion part broke during use in an unspecified procedure on (b)(6) 2023.No piece broke off inside the patient.The procedure was completed successfully.This occurred during use with no patient harm.Additional information has been requested.On 10/2/2023, the arthrex subsidiary employee provided the following information via email: this occurred during a meniscal repair procedure.The complaint device broke during surgery inside the patient.The surgeon could not retrieve all fragments, and part of the product remained in the patient.A new ar-6592-06-30 passport button cannula with an unknown lot number was used to complete the procedure.The complaint device was available for return.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-6592-06-30arthrex passport button cannula¿, 6 mm x 3 cm batch 15103147 was received for evaluation.The visual evaluation reveals that the outer flange was broken off.The most likely cause for the reported failure is a user error mishandling the device.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17958035
• Report Number: 1220246-2023-08239
• Device Sequence Number: 12514308
• 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,Followup
• Report Date (Section B): 08/23/2024

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 Model Number: PASSPORT BUTTON CANNULA
• Device Catalogue Number: AR-6592-06-30
• Device Lot Number: 15103147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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