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

Model Number	SC2101
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This is event 2 of 2 of the same event.It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the motor device would not make a hole with the trepan and the patient's hair started to burn.It was further reported that the surgeon had to make the hole manually with a craniotome instead of the motor device.It was reported that the motor device was in use with the console device when the event occurred.There was a ten minute delay to the surgical procedure due to the event.There was patient involvement.The patient's hair was burned.There was no medical intervention or prolonged hospitalization reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was not confirmed.However a visual and functional assessment was performed on the device which found that the irrigation pump light did not turn on.It was determined that this was consistent with normal use and servicing over time, the failure was caused by worn out touch pad.The assignable root cause was determined to be due to wear from normal use and servicing over time.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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 33410
• MDR Report Key: 7123491
• Report Number: 1045834-2017-50162
• Device Sequence Number: 13808729
• Product Code: HBC
• UDI-Device Identifier: 00845384011972
• UDI-Public: (01)00845384011972(11)130812
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/16/2017

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 Model Number: SC2101
• Device Catalogue Number: SC2101
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1