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

Catalog Number EMAX2PLUS

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

It was reported that during sterile processing, it was observed that there was a problem with the cord on the motor device.During in-house engineering evaluation it was discovered that an unknown liquid was coming out of the connector and cord, there was a cut in the cord exposing wires, and the thermistor failed.The event did not occur during surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, the event was reported to have occurred in (b)(6) 2015.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.(b)(4) evaluated the device and observed that the device had a cut in the cord exposing wires, an unknown liquid was coming out of the connector and cord, the thermistor failed and pretest was unable to be completed.It was determined that the cut in the cord was from allowing the cord to come in contact with a sharp object.It was determined that the thermistor failed because of the unknown substance.The device showed signs of damage that was indicative of damage caused by the sterilization process/immersion during cleaning which is failure to follow the directions for use.The assignable root cause was determined to be due to misuse, abuse, and/or user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 4733146
• MDR Text Key: 5582221
• Report Number: 1045834-2015-10987
• 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: 04/03/2015

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: 04/13/2015
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1