FDA Adverse Event
Other
Summary report: N
*
MDR report key: 1080690
·
Received July 1, 2008
Report
- Report Number
- 1222081-2008-00014
- Event Type
- Other
- Date Received
- July 1, 2008
- Manufacturer
- *
- Product Code
- GFF
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
SUBJECT INSTRUMENT WAS EVALUATED AND BURR SHAFT WAS FOUND TO BE BENT. THERE WAS GALLING IN THE CENTER OF THE BURR FOR ABOUT 1/3 THE LENGTH AND SMALL SCORING MARKS ON THE HUB. THE BENT SHAFT IS AN INDICATION OF POSSIBLE EXCESSIVE SIDE LOAD PRESSURE CAUSING INNER TUBE TO COME IN CONTACT WITH THE OUTER. THIS FRICTION CAN PRODUCE HEAT. IT APPEARS THAT THE BURR WAS OPERATED UNDER CONSIDERABLE PRESSURE AND MAY HAVE BEEN OPERATED DRY CONTRARY TO LABEL WARNINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | * | GFF | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |