FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3140787
·
Received May 31, 2013
Report
- Report Number
- 1045834-2013-02255
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 4, 2013
- Manufacturer
- DEPUY SNYTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- K965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6), STATING THAT DURING A SPINE SURGERY, IT WAS OBSERVED THAT THERE WAS AN "INNER LEAK FROM THE REFURBISHED HOSE ASSEMBLY, " WHICH WAS USED WITH A MOTOR DEVICE. IT WAS REPORTED THAT THE "INNER HOSE IS LOOSENING." THERE WAS A THREE MINUTE DELAY IN THE SURGERY AS A RESULT. AN IDENTICAL SPARE MOTOR DEVICE WAS AVAILABLE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241990 | XMAX MOTOR | DRILL, SURGICAL, ENT (PNEUMATIC)- HANDPIECE | ERL | DEPUY SNYTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |