FDA Adverse Event
Injury
Summary report: N
ITST FEMORAL NAIL
MDR report key: 2925022
·
Received January 17, 2013
Report
- Report Number
- 2648920-2013-00033
- Event Type
- Injury
- Date Received
- January 17, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 21, 2012
- Manufacturer
- ZIMMER
- Product Code
- HSB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS EXPERIENCING PAIN. THE SURGEON CONFIRMED THAT THE NAIL AND CORTICAL SCREW WERE BROKEN. THE PT WAS REVISED FOR THE BROKEN NAIL AND SCREW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 25692 | ITST FEMORAL NAIL | HSB | ZIMMER | 61782879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATALOG #00225303545, LOT #61800243| M/DN INTRAMEDULLARTY FIXATION CORTICAL SCREW: |