FDA Adverse Event
Malfunction
Summary report: N
2.40 MM GUIDE WIRE
MDR report key: 11976276
·
Received June 10, 2021
Report
- Report Number
- 3006460162-2021-00014
- Event Type
- Malfunction
- Date Received
- June 10, 2021
- Manufacturer
- ORTHOPEDIATRICS, CORP
- Product Code
- FZX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WENT IN FOR A STANDARD BLADE PLATE OPERATION. TOOK THE 2.4 THREADED TIP GUIDE WIRE ON A PIN DRIVER AND PUT IT INTO THE PROXIMAL FEMUR. AN X-RAY WAS TAKEN. FROM THERE WE TOOK THE PIN DRIVER BACK TO ADJUST THE GUIDE WIRE, PULLED BACK AND THE GUIDE WIRE SNAPPED. SURGEON WENT TO GRAB IT AGAIN, AND IT SNAPPED AGAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 877249 | 2.40 MM GUIDE WIRE | GUIDE WIRE | FZX | ORTHOPEDIATRICS, CORP | 01-1200-0050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |