FDA Adverse Event
Malfunction
Summary report: N
CORE SUMEX DRILL
MDR report key: 3112253
·
Received May 14, 2013
Report
- Report Number
- 0001811755-2013-01111
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 19, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION, CORROSION WAS FOUND ON THE ATTACHMENT LOCK.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE SUMEX DRILL HEATED UP DURING TESTING BEFORE A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211774 | CORE SUMEX DRILL | DRIVER, WIRE, AND BONE DRILL, MANUAL | DZJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |