MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number 0605887000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the cement did not transfer from the autoplex to the syringe, which caused the tube to expand and the cement to leak.This resulted in a 30 delay to the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

Event Description

It was reported that during a procedure the cement did not transfer from the autoplex to the syringe, which caused the tube to expand and the cement to leak.This resulted in a 30 delay to the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported condition was confirmed to be related to an issue with the transfer tube that connects the mixing chamber with the injector assembly.Subject tubing inflated in such a way that it burst during cement transfer.Further inspection disclosed the inflation/burst was caused by a glue clog at the connector¿s end which did not allow the cement to flow to the injector.The device was scrapped at the manufacturer.

• Brand Name: AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 4058727
• MDR Text Key: 4903100
• Report Number: 0001811755-2014-03138
• Device Sequence Number: 1
• Product Code: OAR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0605887000
• Device Lot Number: 14130012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2014
• 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
• Treatment: VERTAPLEX SPINE CEMENT TWIN CE (B)(4)