FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2200942
·
Received July 1, 2011
Report
- Report Number
- 1811755-2011-02374
- Event Type
- Malfunction
- Date Received
- July 1, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 6, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
WIDE SPREAD CORROSION DAMAGE WAS NOTED WITHIN THE INTERNAL COMPONENTS OF THE DEVICE.
Description of Event or Problem · 1
THE MICRO SAGITTAL SAW WAS SENT IN FOR EVALUATION DUE TO OVERHEATING DURING A PROCEDURE. NO ADVERSE EVENT WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE REPLACEMENT DEVICE; A FIVE TO TEN MINUTE PROCEDURE DELAY WAS REPORTED.
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 |