FDA Adverse Event
Malfunction
Summary report: N
MOTOR ASSEMBLY, XMAX
MDR report key: 3182121
·
Received June 21, 2013
Report
- Report Number
- 1045834-2013-02571
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Report Date
- May 3, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- K965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.(B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(4) STATING THAT THE DEVICE HAD A HOLE/CUT IN THE HOSE (EXCLUDING RUPTURE). THE DEVICE WAS NOT BEING USED DURING SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION PROVIDED. THE DATE OF THE EVENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283540 | MOTOR ASSEMBLY, XMAX | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) - HANDPIECE | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |