MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC CONSOLE, EMAX 2 PLUS; ELECTRONIC DEVICE

Catalog Number SC2100

Device Problem Device Inoperable (1663)

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

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

Event Description

This is event 3 of 3 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device did not work even after the foot switch was stepped on while in use with the console device.It was unknown if there were delays to the surgical procedure or if a spare device was available for use.There was patient involvement.There were no reports of 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 date the device was returned to manufacture was reported as mar 23, 2018 in the initial report.This date has been updated to jul 18, 2018.This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device ac assembly ground lug was broken off and the chassis was dented.This damage was consistent with mishandling of the device by dropping or hitting the device against something.Therefore, the 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.

• Brand Name: CONSOLE, EMAX 2 PLUS
• Type of Device: ELECTRONIC DEVICE
• 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: 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 7432409
• MDR Text Key: 105540322
• Report Number: 1045834-2018-50798
• Device Sequence Number: 1
• Product Code: HBC
• UDI-Device Identifier: 845384008606
• UDI-Public: (01)845384008606(11)120316
• 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,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SC2100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2012
• 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