FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 1972737
·
Received January 21, 2011
Report
- Report Number
- 1811755-2011-00188
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- December 29, 2010
- Report Date
- December 29, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE SMOKING WHEN IN USE WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH MOTOR, NOSE CONE, AND BEARING STOP, WERE EACH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN SMOKING DURING A PROCEDURE TO DRILL AN IMPACTED 3RD MOLAR. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE IMPACTION DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |