MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SYSTEM CONSOLE,SINGLE PORT,W/IRRIGATION; MOTOR, SURGICAL INSTRUMENT

Model Number	SC2101
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was determined to be component failure from normal wear.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the that the electronic control unit on the console device was defective.It was further reported that the device had no clear information on the display and the light emitting diodes flashed randomly and therefore no symbols could be seen on the display.It was also determined that the device failed pre-test for motor lock assessment, hand control, rotation direction, air pump test, irrigation pump, foot pedal, foot pedal irrigation control and manual speed control.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2020.All available information has been disclosed.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, SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10072654
• Report Number: 1045834-2020-00812
• Device Sequence Number: 3752659
• Product Code: HBC
• UDI-Device Identifier: 00845384011972
• UDI-Public: 00845384011972
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K080802
• 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
• Report Date (Section B): 02/19/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1