FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 1924690
·
Received December 9, 2010
Report
- Report Number
- 1811755-2010-01987
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- November 17, 2010
- Report Date
- January 22, 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 EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS CORROSION ON THE BEARINGS OF THE DRIVESHAFT AND ROTOR ASSEMBLY, AS WELL AS, A LACK OF LUBRICATION. THE ROTOR, DRIVESHAFT, SPINDLE HOUSING, AND BEARINGS WERE 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 OVERHEATING DURING AN ORAL SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. THE PT WAS NOT AFFECTED. 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 | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |