FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2922603
·
Received January 18, 2013
Report
- Report Number
- 0001811755-2013-00022
- Event Type
- Malfunction
- Date Received
- January 18, 2013
- Date of Event
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW-UP REPORT WILL BE FILED WHEN THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE MOTOR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP. THERE WERE NO REPORTED PATIENT OR USER INJURIES OR ADVERSE CONSEQUENCES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP. THERE WERE NO REPORTED PATIENT OR USER INJURIES OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28012 | CORE IMPACTION DRILL | DRIVER, WIRE, AND BONE DRILL, MANUAL | DZJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |