FDA Adverse Event
Other
Summary report: N
TIP THREADED GUIDE WIRE FOR ORTHOPEDICS
MDR report key: 551141
·
Received February 26, 2004
Report
- Report Number
- 551141
- Event Type
- Other
- Date Received
- February 26, 2004
- Date of Event
- February 2, 2004
- Report Date
- February 26, 2004
- Manufacturer
- SMITH NEPHEW, INC.
- Product Code
- HXI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING THE INTERNAL FIXATION OF AN INTERTROCHANTERIC, SUBTROCHANTERIC FX FRACTURE WITH A TROCHANTERIC INTERLOCKED, INTRAMEDULLARY NAIL, THE NURSE NOTICED THE TIP OF THE GUIDE PIN WAS NOT INTACT. SURGEON WAS NOTIFIED. THE TIP IDENTIFIED BUT WAS UNABLE TO BE RETRIEVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIP THREADED GUIDE WIRE FOR ORTHOPEDICS | ORTHOPEDIC GUIDEWIRE | HXI | SMITH NEPHEW, INC. | H435716311901D | 03JM05935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | NO OTHER THERAPIES |