MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SYSTEM CONSOLE,SINGLE PORT,W/IRRIGATION; MOTOR, DRILL, ELECTRIC - CONSOLE

Catalog Number	SC2101
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was returned for evaluation.During repair, it was determined that the connector was damaged on the device.It was further determined that the display was defective, the socket for the foot pedal was jammed, and the device had an e5 error code.It was noted that the device failed the pre-repair assessments for manual speed, foot pedal, irrigation test, air pump test, rotational speed, rotation direction, hand control and motor test.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.
Event or Problem Description
It was reported from the (b)(6) that during surgery, before use on a patient, it was observed that the console device had an e8 error code and the diodes were functionless.Was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported that there were any 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.
Additional Manufacturer Narrative
The date the device was received by the manufacturer was reported as november 15, 2017 in the initial report and has been updated to november 13, 2017.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYSTEM CONSOLE,SINGLE PORT,W/IRRIGATION
• Common Device Name: MOTOR, DRILL, ELECTRIC - CONSOLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL
• MDR Report Key: 7069817
• Report Number: 1045834-2017-50068
• Device Sequence Number: 69375
• Product Code: HBC
• UDI-Device Identifier: 00845384011972
• UDI-Public: (01)00845384011972(11)140320
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K011444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: SC2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1