FDA Adverse Event
Malfunction
Summary report: N
CORE MICRO DRILL
MDR report key: 1902872
·
Received November 12, 2010
Report
- Report Number
- 1811755-2010-01678
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR SVC AND EVAL. A CONDITION OF THE DEVICE RUNNING ON ITS OWN WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH CORROSION THROUGHOUT THE DEVICE. THE DRIVE PIN, ROTOR, AND MOTOR, ALONG WITH OTHER COMPONENTS WERE REPLACED.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED TO THE MFR FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE RAN ON ITS OWN. THERE WERE NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE MICRO DRILL | POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |