FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3963913
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-14838
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- 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
- 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. REF: (B)(4).
Description of Event or Problem · 1
REPORT REC'D FROM USA STATING THAT THE DEVICE HAD AN ISSUE WITH INTERMITTENT OPERATION. IT IS KNOWN THE DEVICE WAS USED DURING SURGERY. IT IS KNOWN NO INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652891 | XMAX MOTOR | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |