FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3884630
·
Received June 19, 2014
Report
- Report Number
- 1045834-2014-12341
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 30, 2014
- Report Date
- May 30, 2014
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- PK080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR OVER TIME. 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 ENGINEERING EVALUATION, THE MOTOR DEVICE WAS OVER HEATING. THIS EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. IF ANY ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, THIS NOTIFICATION WILL BE UPDATED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361501 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC - HANDPIECE | HBC | DEPUY SYNTHES POWER TOOLS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |