FDA Adverse Event
Other
Summary report: N
TIBIA/LATERAL COUNTERTRACTION SUPPORT
MDR report key: 293566
·
Received August 28, 2000
Report
- Report Number
- 1043572-2000-00004
- Event Type
- Other
- Date Received
- August 28, 2000
- Date of Event
- July 28, 2000
- Report Date
- July 28, 2000
- Manufacturer
- STERIS CORPORATION
- Product Code
- JEB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE EVENT OCCURRED TOWARDS THE END OF A RETROGRADE IM NAILING ORTHOPEDIC PROCEDURE, TO REPAIR A DISTAL FRACTURE OF THE FEMUR. THE PT'S AFFECTED LEG WAS SUPPORTED BY THE J-BAR SUPPORT PAD. THE DR REPORTED THAT HE WAS MANUALLY PULLING THE AFFECTED LEG AT THE CALF WITH ONE HAND AND HAMMERING THE NAIL AT THE INSERTION POINT WITH THE OTHER HAND. REPORTEDLY, THE SUPPORT POST OF THE TIBIA/LATERAL COUNTERTRACTION SUPPORT SLIPPED OR MOVED AND THERE WAS A COMPLETE BREAK OF THE PT'S FEMUR. THE SURGEON REPAIRED THE FEMUR FRACTURE WITH A PLATE. ACCORDING TO THE HOSP, THE PT IS RECOVERING AND PT'S RATE OF RECOVERY SHOULD BE UNAFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIA/LATERAL COUNTERTRACTION SUPPORT | TABLE ACCESSORY | JEB | STERIS CORPORATION | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |