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

Catalog Number E-FP_LL

Device Problems Misconnection (1399); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product made prior to compliance date (b)(4).The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition of the connector on the device just spins and not attaching could not be confirmed but the cord needed repair was confirmed.It was determined that the damaged cord was consistent with mishandling of the device by allowing the cord to come in contact with a sharp object which damaged the cord or exerting extreme force on the cord during cleaning or use.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.

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the connector on the foot control device would spin but was not attaching.It was reported that the device was damaged by a cart in surgery and needed repair.It was also stated that the cord needed repaired and was damaged even more post-procedure when it was disassembled.There were no delays in the surgical procedure and the same device was able to be used in order to complete the procedure.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.

• Brand Name: ELECTRIC SYSTEMS FOOT CONTROL
• 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: 6943456
• MDR Text Key: 89108997
• Report Number: 1045834-2017-12210
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E-FP_LL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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