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

Catalog Number EMAX2PLUS

Device Problems Difficult to Insert (1316); Difficult To Position (1467); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The actual device has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was observed the motor device was making a high pitch sound when burring.It was further reported that the burr device seemed to dislodge from the motor device and was protruding almost all the way out of the attachment device.According to the reporter, the motor device may have been misassembled initially so the burr device was reengaged and the motor was rehomed.It was reported that the same event occurred when burring was restarted.After the procedure, a drill test was ran with the same drill with a new burr device to see if the malfunction of the burr device falling out could be replicated but was unsuccessful.However, when the burr device was removed it was observed that it was warped in some way and could not be inserted down the long attachment.It was not reported if there was a delay in the procedure due to the event.It was not reported if a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The reporter stated that there was no complaint against the attachment device or the burr devices.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 device was making a high pitch sound when burring and the burr device seemed to dislodge from the motor device and was protruding almost all the way out of the attachment device was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device failed noise and temperature assessments.During repair it was found that the device had a broken drive shaft, causing it to fail noise and temperature assessments.It was determined that this condition was due to excessive force when using the device.It was further determined that using too much force when in use caused drive shaft to break in half.It was determined that this due to user error.If additional information should become available, a supplemental medwatch report 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: 7403793
• MDR Text Key: 105163497
• Report Number: 1045834-2018-50714
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384002055
• UDI-Public: (01)845384002055(11)131220
• 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: company representative,user f
• 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: 04/06/2018
• 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: 04/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2013
• 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