FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 1854390
·
Received September 30, 2010
Report
- Report Number
- 1811755-2010-01274
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN REC'D AT THE MFR FOR INVESTIGATION. ACCORDING TO THE INVESTIGATION DETAILS, THE DEVICE REGISTERED HOT DURING TESTING. THE CONTACT PINS IN THE MOTOR CARTRIDGE APPEARED BURNT AND THE ROTOR ASSEMBLY WAS JAMMED IN THE MOTOR ASSEMBLY. THE MOTOR CARTRIDGE AND ROTOR ASSEMBLY WILL BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURY, AND THE CASE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE MICRO DRILL | POWER SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |