FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 3092183
·
Received May 3, 2013
Report
- Report Number
- 0001811755-2013-01010
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
UPON DISASSEMBLY FOR VISUAL INSPECTION CORROSION WAS FOUND ON THE MOTOR ASSEMBLY.
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.
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 |
|---|---|---|---|---|---|---|---|
| 193744 | CORE IMPACTION DRILL | DRIVER, WIRE, AND BONE DRILL, | DZJ | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |