FDA Adverse Event
Malfunction
Summary report: N
CORE SUMEX DRILL
MDR report key: 3092146
·
Received May 3, 2013
Report
- Report Number
- 0001811755-2013-01006
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 10, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON EVALUATION, THE ROTOR AND DRILL COIL ASSEMBLY WERE FOUND TO BE DAMAGED/WORN, AS WELL AS THE MOTOR END.
Description of Event or Problem · 1
THE CORE SUMEX DRILL WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT MESSAGE WHEN CONNECTED TO THE CONSOLE SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 194203 | CORE SUMEX DRILL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |