FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 1873413
·
Received September 17, 2010
Report
- Report Number
- 1811755-2010-01206
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 20, 2010
- Report Date
- August 23, 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 HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE ROTOR WAS WORN. THE DRIVESHAFT, ROTOR, AND SPINDLE HOUSING WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. AT THIS TIME, IT IS UNK IF THERE WAS PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION FROM THE ACCOUNT WERE UNSUCCESSFUL.
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 |