FDA Adverse Event
Malfunction
Summary report: N
CORE UNIVERSAL DRIVER
MDR report key: 2902032
·
Received November 26, 2012
Report
- Report Number
- 1811755-2012-04151
- Event Type
- Malfunction
- Date Received
- November 26, 2012
- Date of Event
- October 24, 2012
- Report Date
- October 24, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY, IT WAS DISCOVERED THAT THE MOTOR, TRIGGER FLEX, ROTOR, AND GEAR TRAIN WERE WORN.
Description of Event or Problem · 1
THE CORE UNIVERSAL DRIVER WAS RETURNED FOR SERVICE. UPON EVAL AT THE MFR, IT DISPLAYED A BIAS CURRENT ERROR WHEN CONNECTED TO THE CONSOLE, SIGNALING A CONDITION OCCURRED FROM WHICH THE DEVICE HAS THE POTENTIAL TO RUN W/O USER ACTIVATION. THERE WAS NO PT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE UNIVERSAL DRIVER | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |