FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3984317
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-16083
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Report Date
- July 18, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- K965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 PROGRESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THERE WAS A HOLE IN THE DEVICE. THE DEVICE WAS BEING USED DURING SURGERY, BUT NO PATIENT OR USER INJURY OCCURRED. IT IS UNK IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THE DATE OF THE EVENT IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664048 | XMAX MOTOR | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |