FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 MOTOR
MDR report key: 3811236
·
Received October 11, 2013
Report
- Report Number
- 1045834-2013-04722
- Event Type
- Malfunction
- Date Received
- October 11, 2013
- Date of Event
- November 2, 2011
- Report Date
- November 2, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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. (B)(4).
Description of Event or Problem · 1
REPORT REC'D FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING" DURING SURGERY. IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY BUT NO PT OR USER INJURY OCCURRED. IT IS UNK IF THE DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523978 | EMAX 2 MOTOR | MOTOR, DRILL, ELECTRIC - HANDPIECE, PRODUCT CODE: HBC | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |