FDA Adverse Event
Other
Summary report: N
*
MDR report key: 974955
·
Received May 25, 2007
Report
- Report Number
- 9610617-2007-00014
- Event Type
- Other
- Date Received
- May 25, 2007
- Manufacturer
- *
- Product Code
- EZO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE BLADE AND ATTACHED SHAFT (2 CM IN LENGTH TOTAL) WAS RETURNED FOR EVAL. THIS IS THE BROKEN PIECE THAT WAS RETRIEVED FROM THE PT. THE BLADE OF THE SHAFT SHOWS A LOT OF STRIATIONS ALONG THE FACE OF THE BLADE; IT APPEARS TO HAVE BEEN IN HEAVY USE. THERE APPEARS TO BE GOUGED METAL ON THE TIP AND THERE ARE SOME NICKS IN THE METAL ALONG THE EDGE OF THE CUTTING/BLADE SURFACE. THERE IS NO DEFECT OR CORROSION VISIBLE IN THE SHAFT METAL AT POINT OF BREAKAGE. THERE IS NO DEFECT TREND REPORTED ON THIS DEVICE. WE BELIEVE THE CONDITION OF THIS INSTRUMENT IS CONSISTENT WITH DAMAGE CAUSED BY MECHANICAL OVERLOAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | EZO | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |