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

Model Number EMAX2PLUS

Device Problems Overheating of Device (1437); Smoking (1585); Device Inoperable (1663); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

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 is report 1 of 3 for the same event.It was reported that during an ear nose and throat procedure, it was observed that the motor device and two attachment devices had warmth building in the surgeons hand after several minutes of holding the drill.It was also reported that smoke and metal shavings were then witnessed after which time the drilling was ceased.It was not reported if there were any delays in the surgical procedure.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

This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device was found to be overheated and making a loud noise.Therefore, the reported condition was confirmed.The reported condition that the device had metal shavings was not confirmed.It was also noted that the bearings were found to be worn out which caused the heat and noise.The assignable root cause was determined to be due to wear from normal use and servicing.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: 7432658
• MDR Text Key: 105675318
• Report Number: 1045834-2018-50787
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 00845384002055
• UDI-Public: (01)00845384002055(11)090319
• 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: 03/26/2018

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 Model Number: EMAX2PLUS
• Device Catalogue Number: EMAX2PLUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2009
• 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