MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX W/O NEEDLE; MIXER, CEMENT FOR CLINICAL USE

Catalog Number 0605687015

Device Problem Disassembly (1168)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2014

Event Type  malfunction  

Event Description

It was reported that the autoplex system was being used in a procedure when it burst.The procedure was completed successfully using a back up device.There were no patient or user injuries, and no adverse consequences.

Event Description

It was reported that the autoplex system was being used in a procedure when it burst.The procedure was completed successfully using a back up device.There were no patient or user injuries, and no adverse consequences.

Manufacturer Narrative

A follow up report will be filed after the device is received and the quality investigation has been completed.

Manufacturer Narrative

The device was evaluated and the reported event was confirmed.A definite root cause could not be determined.The device was scrapped at the manufacturer.

• Brand Name: AUTOPLEX W/O NEEDLE
• Type of Device: MIXER, CEMENT FOR CLINICAL USE
• 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: 4168743
• MDR Text Key: 5090706
• Report Number: 0001811755-2014-03583
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0605687015
• Device Lot Number: 14164012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 10/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2014
• 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