FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2853987
·
Received October 24, 2012
Report
- Report Number
- 1811755-2012-03886
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 21, 2012
- Report Date
- September 25, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A PROCEDURE. THERE WERE NO PT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.
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 |