MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC ELECTRIC SYSTEMS FOOT CONTROL; MOTOR, DRILL, ELECTRIC - FOOT CONTROL

Model Number	E-FP
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that during an unspecified surgery of the spine, it was observed that the foot plate on the foot control device came off.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.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.
Additional Manufacturer Narrative
The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition that the foot plate came off (had the base torn away from plate) from "housing") was confirmed.A visual and functional assessment was performed on the device which found that the base plate broken off housing.The assignable root cause was determined to be due to mishandling by dropping or hitting the device against something breaking the base plate of the housing, which is user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ELECTRIC SYSTEMS FOOT CONTROL
• Common Device Name: MOTOR, DRILL, ELECTRIC - FOOT CONTROL
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7439480
• Report Number: 1045834-2018-50808
• Device Sequence Number: 1006525
• Product Code: HBC
• UDI-Device Identifier: 00845384011767
• UDI-Public: (01)00845384011767(11)140912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2018

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: E-FP
• Device Catalogue Number: E-FP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 05/21/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 05/08/2018; 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1