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

Catalog Number 0306330000

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 2 device investigation types have not yet been determined.Additional information: 2 devices were labeled for single-use.2 devices were not reprocessed or reused.

Event Description

This report summarizes 2 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 2 events were originally reported for this failure mode during the reporting quarter; however, 5 events were inadvertently excluded.7 reported events are included in this follow-up record.Product return status: 7 device investigation types have not yet been determined.

Event Description

This report summarizes 7 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.5 events had insufficient information received.

Event Description

This report summarizes 7 malfunction events in which the device or cutting accessory fractured.- 2 events had patient involvement; no patient impact.- 5 events had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h10 7 previously reported events are included in this follow-up record.Product return status 6 devices were not available for evaluation.1 device investigation type has not yet been determined.

Event Description

This report summarizes 7 malfunction events in which the device or cutting accessory fractured.2 events had patient involvement; no patient impact.5 events had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: h10.7 previously reported events are included in this follow-up record.Product return status: 1 device was received.6 devices were not available for evaluation.

• Brand Name: 11G IVAS ACCESS CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 12715270
• MDR Text Key: 279530950
• Report Number: 3015967359-2021-02423
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 37613252505991
• UDI-Public: 37613252505991
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0306330000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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