FDA Adverse Event
Malfunction
Summary report: N
LOANER CORE IMPACTION DRILL
MDR report key: 1791642
·
Received July 29, 2010
Report
- Report Number
- 1811755-2010-00858
- Event Type
- Malfunction
- Date Received
- July 29, 2010
- Date of Event
- March 29, 2010
- Report Date
- March 29, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND EVALUATION. A CONDITION OF THE DEVICE OVERHEATING WAS REPORTED. BASED ON THE REPAIR DETAILS, A POSSIBLE CAUSE FOR THE OVERHEATING WAS A FAILED ROTOR WITH A WORN COUPLER. THE ROTOR, BEARINGS, NOSE CONE, AND BEARING STOP WERE EACH REPLACED. SERVICE REPAIRED THE HANDPIECE AND DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING AN ORAL SURGERY. THE PROCEDURE WAS SUCCESSFULLY 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 | LOANER CORE IMPACTION DRILL | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |