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

Catalog Number CAT02439

Device Problem Fracture (1260)

Patient Problem Scar Tissue (2060)

Event Date 03/28/2024

Event Type  Injury  

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 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.

• Brand Name: FLOWPORT II CANNULA WITH OBTURATOR, ARTHREX
• Type of Device: 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 19188251
• MDR Text Key: 341114491
• Report Number: 0002936485-2024-00355
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 07613327405866
• UDI-Public: 07613327405866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other