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

Model Number EMAX2PLUS

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report 1 of 3 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the motor device was very loud during bone removal of the femur.According to the report, the device was being used with an attachment device and a burr device.It was further reported that the noise was believed to be caused by a faulty attachment device.Subsequently, it was reported that the system displayed an error of the handpiece or drill communication error that the device had to re-calibrated and home.It was reported that the burring was quieter after that.However, once completed, it was reported that the drill was difficult to remove and the burr device was difficult to remove from the attachment device.It was reported that there were no delays in the surgical procedure and a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the drill was very loud during bone removal was confirmed.However, the device did not give a system error nor was the drill device nor the burr device was difficult to remove from the attachment device.A visual and functional assessment was performed on the device which found that the device failed noise and temperature assessments.It was determined that the device heated up over specification in five minutes.Furthermore, it was determined that during repair, the device had a broken drive shaft causing it to fail noise and temperature assessments.It was determined that this was consistent with excessive force when using the device, using too much force when in use causing drive shaft to break in half (user error).The assignable root cause was determined to be due to user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: EMAX 2 PLUS MOTOR
• Type of Device: MOTOR, DRILL, ELECTRIC - HANDPIECE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7395193
• MDR Text Key: 104543461
• Report Number: 1045834-2018-50693
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384002055
• UDI-Public: (01)00845384002055(11)141125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EMAX2PLUS
• Device Catalogue Number: EMAX2PLUS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1