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

Model Number	E-FP-DIR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the foot control device had exposed wires.This event did not occur during surgery.There was no 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.
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the cord was damaged preventing the function assessment from being performed and the housing was damaged.Therefore, the reported condition was confirmed.It was further determined that the damaged cord is consistent with mishandling of the device by allowing the cord came in contact with a sharp object which damaged the cord or exerting extreme force on the cord during cleaning or use (user error).The damaged housing is consistent with mishandling by dropping or hitting the device against something breaking the base plate of the housing (user error).The assignable root cause was determined to be due to user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ELECTRIC SYSTEMS FOOT CONTROL WITH DIR
• 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: 7182561
• Report Number: 1045834-2018-50051
• Device Sequence Number: 13758791
• Product Code: HBC
• UDI-Device Identifier: 00845384011750
• UDI-Public: (01)00845384011750(11)110713
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: E-FP-DIR
• Device Catalogue Number: E-FP-DIR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1