FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 3023055
·
Received March 27, 2013
Report
- Report Number
- 0001811755-2013-00619
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 7, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION, CORROSION WAS FOUND ON THE BEARING MOUNT, SOCKETS, ROTOR AND WAVESPRING WASHER.
Description of Event or Problem · 1
IT WAS REPORTED DURING USE THAT THE CORE MICRO DRILL CONTINUED TO RUN WHEN THE TRIGGER WAS NO LONGER ACTIVATED. THERE WAS NO PATIENT OR USER ADVERSE CONSEQUENCE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125955 | CORE MICRO DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |