FDA Adverse Event
Malfunction
Summary report: N
CORE IMPACTION DRILL
MDR report key: 2896553
·
Received November 20, 2012
Report
- Report Number
- 1811755-2012-04138
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 31, 2012
- Report Date
- November 1, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETED. IF ADDITIONAL INFO IS OBTAINED AND REQUIRES REPORTING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING EQUIPMENT TESTING CONDUCTED AT THE USER FACILITY, THE DRILL WAS OVERHEATING. NO PT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
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 |