FDA Adverse Event
Malfunction
Summary report: N
CORE SUMEX DRILL
MDR report key: 3093525
·
Received May 6, 2013
Report
- Report Number
- 0001811755-2013-01028
- Event Type
- Malfunction
- Date Received
- May 6, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY, THE DRILL COIL ASSEMBLY AND MOTOR END WERE FOUND TO BE WORN/DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE SUMEX DRILL RAN WITHOUT USER ACTIVATION. UPON EVALUATION AT THE MANUFACTURER, IT DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE, BUT WERE NOT SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196830 | CORE SUMEX DRILL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |