FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 PLUS MOTOR
MDR report key: 3811823
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-03777
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Report Date
- November 1, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K080802
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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. REF: (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE AND ATTACHMENT "BECAME VERY HOT DURING USE" AND "BURNT THROUGH THE DRAPES" DURING SURGERY. IT IS KNOWN THAT DEVICE WAS BEING USED DURING SURGERY BUT NO PATIENT OR USER INJURY OCCURRED. IT IS UNKNOWN IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523780 | EMAX 2 PLUS MOTOR | MOTOR, DRILL, ELECTRIC - HANDPIECE | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |