FDA Adverse Event Malfunction Summary report: N

EMAX 2 MOTOR

MDR report key: 3874703 · Received June 16, 2014

Report

Report Number: 1045834-2014-12278
Event Type: Malfunction
Date Received: June 16, 2014
Date of Event: November 26, 2013
Report Date: November 27, 2013
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HBC
PMA / PMN Number: PK011444
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE. A FUNCTIONAL ASSESSMENT WAS PERFORMED WHICH FOUND THAT THE DEVICE DID NOT ROTATE, DISPLAYING AN E2 ERROR CAUSED BY PINS BEING PUSHED BACK IN THE CONNECTOR. THE PIN PUSHED BACK IN THE CONNECTOR WAS DETERMINED TO BE A RESULT OF THE CONNECTOR NOT BEING PROPERLY ALIGNED AND FORCED INTO THE FEMALE CONNECTOR WHEN PLUGGING IT INTO CONSOLE. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO MISUSE, ABUSE AND/OR USER ERROR. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO SURGERY, IT WAS OBSERVED THAT THE MOTOR DEVICE WAS STOPPING INTERMITTENTLY. THERE WERE NO DELAYS TO THE SCHEDULED 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. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352706	EMAX 2 MOTOR	MOTOR, DRILL, ELECTRIC - HANDPIECE	HBC	DEPUY SYNTHES POWER TOOLS		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1