FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 2974629
·
Received January 17, 2013
Report
- Report Number
- 1811755-2013-90095
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 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
FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, THE DEVICE CAUSED A BIAS CURRENT ERROR 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 PT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27204 | CORE MICRO DRILL | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |