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 Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2020

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: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.3 devices were labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device fractured.2 events had no known impact or consequences to the patient.1 event had a foreign body left in the patient.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 3 previously reported events are included in this follow-up record.Product return status: 1 device was not available for evaluation.2 device investigation types have not yet been determined.

Event Description

This report summarizes 3 malfunction events in which the device fractured.1 events had no known impact or consequences to the patient.2 event had a foreign body left in the patient.

Event Description

This report summarizes 3 malfunction events in which the device or cutting accessory fractured.- 1 event had patient involvement; no patient impact.- 2 events which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

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: b5, h10 3 previously reported events are included in this follow-up record.Product return status 1 device was received.2 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
• MDR Report Key: 10330256
• MDR Text Key: 200609015
• Report Number: 0001811755-2020-01944
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 37613252505991
• UDI-Public: 37613252505991
• Combination Product (y/n): N
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0306330000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1