MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS EMAX 2 PLUS MOTOR; MOTOR, DRILL, ELECTRIC - HANDPIECE

Catalog Number EMAX2PLUS

Device Problems Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979)

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

Event Type  malfunction  

Event Description

It was reported that the motor device had an unspecified malfunction.During in-house engineering evaluation, it was observed that the device had an e8 error code, fluid in the connector and a hole in the cord with exposed wires.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Additional narrative: the actual device was returned for evaluation with an unspecified malfunction.Reliability engineering evaluated the device and observed that the device had an e8 error code, fluid in the connector and a hole on the cord with exposed wires.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to misuse, abuse and/or user error.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4489971
• MDR Text Key: 15119105
• Report Number: 1045834-2015-10238
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

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: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1