FDA Adverse Event
Malfunction
Summary report: N
1011-34 AIM FEMORAL NAIL
MDR report key: 198642
·
Received November 18, 1998
Report
- Report Number
- 2020311-1998-00024
- Event Type
- Malfunction
- Date Received
- November 18, 1998
- Date of Event
- February 13, 1998
- Report Date
- October 8, 1998
- Manufacturer
- DEPUY ACE MEDICAL COMPANY
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FEMUR BROKE UPON REMOVAL OF FEMORAL NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1011-34 AIM FEMORAL NAIL Implant | INTRAMEDULLARY NAILS | HSB | DEPUY ACE MEDICAL COMPANY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | TIBIAL SHAFT FRACTURE. |