FDA Adverse Event
Malfunction
Summary report: N
REMB MICRO DRILL
MDR report key: 3143213
·
Received June 3, 2013
Report
- Report Number
- 0001811755-2013-01284
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 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
UPON DISASSEMBLY FOR VISUAL INSPECTION, CORROSION WAS FOUND ON THE MOTOR.
Description of Event or Problem · 1
THE REMB MICRO 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 NO ADVERSE CONSEQUENCES TO THE USER ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244314 | REMB MICRO DRILL | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |