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

Catalog Number EMAX2PLUS

Device Problems Overheating of Device (1437); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 01/01/2018

Event Type  malfunction  

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 temperature of the device was above specification.Therefore, reported condition was confirmed.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.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device was making an abnormal noise and had smoke coming out of it.It was not reported if there was a delay in the procedure due to the event, or 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 exact date of the event was not reported, however, it was noted that the event occurred in 2018.All available information has been disclosed.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: 7340745
• MDR Text Key: 102457916
• Report Number: 1045834-2018-50522
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384002055
• UDI-Public: (01)845384002055(11)160909
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• 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: 02/20/2018
• Date Manufacturer Received: 02/16/2018
• Date Device Manufactured: 09/09/2016
• 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