FDA Adverse Event
Malfunction
Summary report: N
EMAX 2 MOTOR
MDR report key: 3970113
·
Received December 11, 2013
Report
- Report Number
- 1045834-2013-14563
- Event Type
- Malfunction
- Date Received
- December 11, 2013
- Date of Event
- June 14, 2012
- Report Date
- June 20, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- NOT APPLICABLE
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 INFO BECOME 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 HAD A HOLE IN THE HOSE. THE DEVICE WAS BEING USED DURING SURGERY BUT NO PT OR USER INJURY OCCURRED. IT IS UNK IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 648323 | EMAX 2 MOTOR | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |