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

Model Number 0306-330-000

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2023

Event Type  malfunction  

Event Description

After successful l2 bone biopsy; l1-2 disk biopsy; attempt was made to remove stryker ivas 11g access cannula; reference #0306-330-000 lot #22313012.Upon removal device fragmented.Per the markers on the device approximately 2.5cm was retained.8.5cm was removed.Permanent images were obtained and stored to medical record.Rest of device along with original packaging was saved for supply manager.Note was left in for your information in epic.No harm to patient noted as fragment is in bone.

• Brand Name: STRYKER IVAS 11G ACCESS CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS
• MDR Report Key: 16963006
• MDR Text Key: 315767622
• Report Number: MW5117709
• Device Sequence Number: 1
• Product Code: OAR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• 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 Lot Number: 22313012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White