MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS FOOT CONTROL, SC2100; MOTOR, DRILL, ELECTRIC - FOOT CONTROL

Catalog Number EPLUS-FP_LL

Device Problems Material Protrusion/Extrusion (2979); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2014

Event Type  malfunction  

Event Description

It was reported that the cable instillation of the foot pedal device was torn and wires were exposed.It was not reported that the malfunction occurred during surgery.It was not reported that there were any delays in the surgical procedure or if a spare device was available for use.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 report will be submitted accordingly.

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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

During subsequent follow-up with the reporter, additional information was obtained.The reporter clarified that the event occurred during pre-surgery.There were no delays to the planned surgical procedure as an identical spare device was available for use.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device had a torn cord, with exposed wires.Therefore, the reported condition was confirmed.It was determined that the hole in cord was due to mishandling of the device by allowing the cord to come in contact with a sharp object which punctured the cord or by exerting extreme force on the cord during cleaning or use.The assignable root cause was determined to be due to misuse, abuse and/or user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: FOOT CONTROL, SC2100
• Type of Device: MOTOR, DRILL, ELECTRIC - FOOT CONTROL
• Manufacturer (Section D): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES POWER TOOLS; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: rodney crain ; 4500 riverside drive; palm beach gardens, FL 33410 ; 5616271080
• MDR Report Key: 4237748
• MDR Text Key: 4975239
• Report Number: 1045834-2014-14804
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: EPLUS-FP_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2014
• Initial Date FDA Received: 11/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1