MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLOWPORT II CANNULA WITH OBTURATOR, ARTHREX; ACCESSORIES, ARTHROSCOPIC

Catalog Number	CAT02439
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Scar Tissue (2060)
Date of Event	03/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that a flowport cannula broke off at the distal tip where the metal moves to polymer.It was upon insertion into the joint space, the broken portion got stuck in the joint space.After trying to remove for over 30 min, the decision was made to convert to an open procedure from a scope.The procedure was delayed 2.5 hours and patient had more time under anesthesia and a larger scar.
Event or Problem Description
It was reported that a flowport cannula broke off at the distal tip where the metal moves to polymer.It was upon insertion into the joint space, the broken portion got stuck in the joint space.After trying to remove for over 30 min, the decision was made to convert to an open procedure from a scope.The procedure was delayed 2.5 hours and patient had more time under anesthesia and a larger scar.
Additional Manufacturer Narrative
Alleged failure: from sales rep: dr.(b)(6) has used our flowport cannulas (cat02439) many times for many cases and just recently had some break.Today 2 flowport cannulas broke off at the distal tip where the metal moves to polymer.Both times were upon insertion into the joint space and as you¿ll see from the pictures, the broken portion got stuck in the joint space.After trying to remove for over 30 min, the decision was made to convert to an open procedure from a scope.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR, ARTHREX
• Common Device Name: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19188251
• Report Number: 0002936485-2024-00355
• Device Sequence Number: 8294739
• Product Code: NBH
• UDI-Device Identifier: 07613327405866
• UDI-Public: 07613327405866
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CAT02439
• Device Lot Number: 010890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown