FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 3002665
·
Received March 13, 2013
Report
- Report Number
- 0001811755-2013-00516
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 13, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORROSION WAS DISCOVERED INTERNALLY, AS WELL AS BROKEN/DISASSEMBLED COMPONENTS.
Description of Event or Problem · 1
THE CORE MICRO DRILL WAS RETURNED FOR SERVICE. UPON EVALUATION AT THE MANUFACTURER, IT WAS FOUND TO DISPLAY 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. 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 |
|---|---|---|---|---|---|---|---|
| 104679 | CORE MICRO DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |