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

Catalog Number EMAX2PLUS

Device Problems Overheating of Device (1437); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2017

Event Type  malfunction  

Manufacturer Narrative

Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device overheated.It was further reported that the device was unable to reach the speed limit and smoke was coming out of the device.There were no delays in the surgical procedure as a spare device was available for use.It was reported that the surgical procedure was completed.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

Device was used for treatment, not diagnosis.The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.The motor device was evaluated and it was determined that the drive shaft had come apart.It was noted that the drive shaft was defective, badly corroded, and broken.It was further determined that the device failed pretest for loctite and cable assessments, cutter lock assessment, and safety assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to premature wear.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
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens ; 5616271080
• MDR Report Key: 7121105
• MDR Text Key: 95458996
• Report Number: 1045834-2017-50178
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384002055
• UDI-Public: (01)845384002055(11)090902
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 12/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2009
• 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