FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2233166
·
Received July 22, 2011
Report
- Report Number
- 1811755-2011-02634
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING FAILURE ANALYSIS, THIRD PARTY REPAIR WORK WAS NOTED.
Description of Event or Problem · 1
THE MICRO SAGITTAL SAW WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING TESTING. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |