FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3123918
·
Received May 22, 2013
Report
- Report Number
- 1045834-2013-02159
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION. THE MOTOR DEVICE WAS TESTED AND MET TEMPERATURE SPECIFICATIONS. THE REPORTED CONDITION WAS NOT CONFIRMED. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA REGARDING A MOTOR DEVICE IN WHICH, DURING ROUTINE INSPECTION, IT AS DISCOVERED THAT THE MOTOR DEVICE WAS "OVERHEATING" AND "GETTING WARM TO THE TOUCH". THE MOTOR DEVICE WAS NOT USED IN SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226077 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC- HANDPIECE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |