FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE MICRO DRILL
MDR report key: 2043355
·
Received March 15, 2011
Report
- Report Number
- 1811755-2011-00818
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- January 18, 2011
- Report Date
- February 21, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED FOR EVALUATION; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
A STRYKER CORE MICRO DRILL WAS SENT IN FOR REPAIR DUE TO OVERHEATING, DISCOVERED DURING ROUTINE QUALITY CHECK AT THE HOSPITAL. NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR CORE MICRO DRILL | BONE CUTTING INSTRUMENT AND ACCESSORIES | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |