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

Catalog Number	AR-6592-08-30
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that a section of distal flange was torn from the passport cannula.The observed condition is most likely caused by improper technique such as incorrect instruments used to insert the passport cannula, incorrect portal incision size, excessive force applied during insertion and/or by use of a sharp instrument.This is the second complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a case, the surgeon attempted to introduce an arthrex passport button cannula in the standard way using a hemostat.The distal tip of the cannula, the part that was grasped with the hemostat, broke off outside of the joint.The incision had to be slightly extended to retrieve the broken piece and the case was completed without further incident.Follow-up investigation: facility reporter confirmed that information previously reported is correct.Per reporter the smaller fragment piece, that was removed from the patient, was discarded in the trash at time of procedure and was not being returned with remaining portion of device.

• Brand Name: ARTHREX PASSPORT BUTTON CANNULA
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7230312
• Report Number: 1220246-2018-00021
• Device Sequence Number: 1173430
• Product Code: MDM
• UDI-Device Identifier: 10888867040592
• UDI-Public: 10888867040592
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: AR-6592-08-30
• Device Lot Number: 10112601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other