FDA Adverse Event
Malfunction
Summary report: N
CORE UNIVERSAL DRIVER
MDR report key: 2964580
·
Received February 15, 2013
Report
- Report Number
- 0001811755-2013-00299
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 30, 2013
- Report Date
- January 30, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRINTED CIRCUIT BOARD (FLEX ASSEMBLY) WITHIN THE MOTOR WAS FOUND TO BE DAMAGED, WHICH IS A PROBABLE CAUSE OF THE BIAS CURRENT ERROR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY THE DEVICE CAUSED A BIAS CURRENT WARNING TO BE DISPLAYED ON THE CONSOLE, SIGNALING A CONDITION OCCURRED IN WHICH THE DEVICE HAS THE POTENTIAL TO RUN WITHOUT USER ACTIVATION. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66466 | CORE UNIVERSAL DRIVER | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |