FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3984208
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-14881
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- December 9, 2011
- Report Date
- December 9, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS 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.
Description of Event or Problem · 1
REPORT RECEIVED FROM USA STATING THAT THE DEVICE HAD A MOTOR THAT WAS OVER HEATING DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663740 | EMAX 2 PLUS MOTOR | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |