FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2123328
·
Received June 8, 2011
Report
- Report Number
- 1811755-2011-02072
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 11, 2011
- Report Date
- May 13, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE RESULTS ANALYSIS AND THE CONCLUSION IS COMPLETE.
Description of Event or Problem · 1
THE CORE IMPACTION DRILL WAS SENT FOR SERVICE BECAUSE, IT WAS LEAKING OIL JUST PRIOR TO A PROCEDURE; THE DEVICE NEVER CAME IN CONTACT WITH THE PT. ANOTHER DEVICE WAS USED FOR THE PROCEDURE. NO ADVERSE EVENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CORE IMPACTION DRILL | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |