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

Catalog Number E-FP_LL

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Gtin is unavailable as the product made prior to compliance date; (b)(4).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 Description

This is report 1 of 4 for the same event: it was reported that during an unspecified spine surgery, it was discovered that when the foot control device, console device and motor device were being used together, an e5 error code was observed.It was reported that a second motor device was used and did not work.It was reported that there was a five minute delay and no spare device was available for use.It was reported that the user used a different option and the surgical procedure was completed successfully.The reporter did not provide any information regarding the different option used to complete the procedure.There was 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 report will be submitted accordingly.

Manufacturer Narrative

The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the reported condition of the device having e5 error code could not be confirmed.Therefore, an assignable root cause could not be determined.However, it was further observed that the device did not work and the base plate was loose with the wrong screws holding it on and was missing the rest cover.The assignable root cause was determined to be due to an unauthorized repair which is misuse.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 6113068
• MDR Text Key: 60854565
• Report Number: 1045834-2016-13262
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 11/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2010
• 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
• Treatment: CONSOLE DEVICE; MOTOR DEVICES