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

Model Number	PASSPORT BUTTON CANNULA
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/13/2018
Type of Reportable Event	Serious Injury
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 cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a shoulder arthroscopy/asad&rcr procedure, the passport button cannula was hit with another instrument and a piece of the cannula broke off.The fragment that broke off was not able to be found.The patient¿s shoulder was re-examined and still, the missing fragment could not be located.
Additional Manufacturer Narrative
Complaint confirmed.The evaluation confirmed 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.

• Brand Name: 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: 7710760
• Report Number: 1220246-2018-00560
• Device Sequence Number: 19030028
• Product Code: MDM
• UDI-Device Identifier: 00888867040595
• UDI-Public: 00888867040595
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 12/31/2022
• Device Model Number: PASSPORT BUTTON CANNULA
• Device Catalogue Number: AR-6592-08-30
• Device Lot Number: F186010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/21/2018
• 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