FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE MICRO DRILL
MDR report key: 1882933
·
Received October 22, 2010
Report
- Report Number
- 1811755-2010-01461
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 24, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS CONFIRMED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS CORROSION, CAUSING THE ROTOR TO BECOME LODGED IN THE MOTOR. THE MOTOR, DRIVE PIN, AND OTHER COMPONENTS WERE EACH REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. THIS DID NOT OCCUR DURING ANY SURGICAL OR MEDICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE MICRO DRILL | POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |