MAUDE Adverse Event Report: DEPUY SYNTHES POWER TOOLS ELECTRONIC FOOT CONTROL W/DIR ONLY; MOTOR, DRILL, ELECTRIC - FOOT CONTROL

Catalog Number E-FP-DIR

Device Problem Degraded (1153)

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

Event Type  malfunction  

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 Description

It was reported that the electronic foot control device had exposed wires.The event was not reported to have occurred during surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device availability and device manufacture date: device availability: the device availability date was incorrectly documented in the initial report.The date returned to manufacturer date was corrected from mar 16, 2016 to mar 11, 2016.Device manufacture date: the device manufacture date was incorrectly documented as may 2, 2010.The device manufacture date has been updated to may 21, 2010.Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the cord was torn, exposing the wires.It was further determined that the torn cord was consistent with mishandling of the device by allowing the cord to come in contact with a sharp object which punctured the cord or exerting extreme force on the cord during cleaning or use.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user error.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: ELECTRONIC FOOT CONTROL W/DIR ONLY
• 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: 5507743
• MDR Text Key: 40812836
• Report Number: 1045834-2016-10816
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E-FP-DIR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1