FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3811251
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-13060
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Date of Event
- May 23, 2011
- Report Date
- May 24, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE IS CURRENTLY UNDERGOING EVALUATION. WHEN THE EVALUATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).
Description of Event or Problem · 1
REPORT FROM THE (B)(6) STATED THAT THERE WAS CORD DAMAGE. IT IS KNOWN THAT THE DEVICE WAS NOT USED DURING SURGERY. IT IS UNKNOWN IF INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523998 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC - HANDPIECE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |