FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3811284
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-13078
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- December 16, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE DID NOT FUNCTION. THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF THERE WERE ANY PATIENT OR USER INJURIES REPORTED. IT IS UNKNOWN IF MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 524265 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC - HANDPIECE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |