MAUDE Adverse Event Report: STRYKER STRYKER FLOWPORT CANNULA

Model Number FLOW PORT 11CANNULA

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/25/2016

Event Type  malfunction  

Event Description

A stryker flowport cannula broke during an arthroscopy of a hip.A small section was retained in the soft tissue of the pt's right hip.It was deemed safer to leave the object in the pt that continue with the attempted removal.Flowport ii cannula (2) with obturator (1) stryker, 165mm, product ref number (b)(4), lot #16042101, expiration: 04/21/2018.

• Brand Name: STRYKER FLOWPORT CANNULA
• Type of Device: STRYKER FLOWPORT CANNULA
• Manufacturer (Section D): STRYKER
• MDR Report Key: 6080900
• MDR Text Key: 59405976
• Report Number: MW5065822
• Device Sequence Number: 1
• Product Code: NBH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2018
• Device Model Number: FLOW PORT 11CANNULA
• Device Catalogue Number: CAT02438
• Device Lot Number: 16042101
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR