FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 3051632
·
Received April 10, 2013
Report
- Report Number
- 0001811755-2013-00754
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION NO PROBLEM WAS FOUND AND OVERHEATING WAS NOT OBSERVED AFTER EXTENSIVE TESTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CORE IMPACTION DRILL HEATED UP DURING A CASE. THERE WAS NO PATIENT OR USER INJURY REPORTED AND NO ADVERSE CONSEQUENCES ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153439 | CORE IMPACTION DRILL | DRIVER, WIRE, AND BONE DRILL, | DZJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |