FDA Adverse Event Malfunction Summary report: N

EMAX 2 PLUS MOTOR

MDR report key: 4182839 · Received October 17, 2014

Report

Report Number: 1045834-2014-14599
Event Type: Malfunction
Date Received: October 17, 2014
Date of Event: October 3, 2014
Report Date: October 3, 2014
Manufacturer: DEPUY SYNTHES POWER TOOLS
Product Code: HBC
PMA / PMN Number: PK080802
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE HAD AN E6 ERROR CODE AND THE THERMISTOR WAS BAD. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. IT WAS DETERMINED THA THE E6 ERROR CODE WAS A RESULT OF THE BAD THERMISTOR. IT WAS DETERMINED THAT THE BAD THERMISTOR WAS DUE TO CORROSION FROM THE STERILIZATION PROCESS/IMMERSION. 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 DURING AN UNSPECIFIED SPINE SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE MOTOR DEVICE WAS RECEIVING ERROR CODE E6. THERE WERE NO DELAYS TO THE PLANNED SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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
661368	EMAX 2 PLUS MOTOR	MOTOR, DRILL, ELECTRIC - HANDPIECE	HBC	DEPUY SYNTHES POWER TOOLS		NA

Patients

Seq	Age	Sex	Outcome	Treatment
1