FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3811217
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-03904
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- July 6, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF#(B)(4).
Description of Event or Problem · 1
REPORT REC'D FROM USA STATING THAT THE DEVICE HAD A WORN HOSE. IT WAS UNK IF THE DEVICE WAS BEING USED DURING SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523897 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC-HANDPIECE, PRODUCT CODE: HBC | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |