MAUDE Adverse Event Report: STRYKER CORPORATION IVAS 11G ACCESS CANNULA; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Model Number 0306-330-000

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

This is the 4th time that the plastic weld to the metal portion of the needles separated while pulling the needle out.Provider had placed the needle through the laminal and in between the thecal sac and the exiting l5 nerve root in approach for a cryoablation of a tumor while making a pilot hole.Upon removal of the needle the metal portion of the needle separated from the handle.

• Brand Name: IVAS 11G ACCESS CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 12413376
• MDR Text Key: 269543928
• Report Number: 12413376
• Device Sequence Number: 1
• Product Code: OAR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0306-330-000
• Device Catalogue Number: 0306-330-000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1