FDA Adverse Event
Malfunction
Summary report: N
XMAX MOTOR
MDR report key: 3250041
·
Received July 26, 2013
Report
- Report Number
- 1045834-2013-03668
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 27, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- ERL
- PMA / PMN Number
- K965080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE MOTOR DEVICE WAS "RUNNING HOT AT THE LOCKING MECHANISM". NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS ALLEGED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350641 | XMAX MOTOR | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |