FDA Adverse Event
Malfunction
Summary report: N
OIC INTRAMEDULLARY NAIL SYSTEM
MDR report key: 10710994
·
Received October 21, 2020
Report
- Report Number
- 10710994
- Event Type
- Malfunction
- Date Received
- October 21, 2020
- Date of Event
- October 5, 2020
- Report Date
- October 8, 2020
- Manufacturer
- ORTHOPAEDIC IMPLANT COMPANY, THE
- Product Code
- HSB
- UDI-DI
- 10811998036851
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- UT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE OR TECHNICIAN WAS PREPARING INSTRUMENTS FOR A CASE. DURING A PRE-RUN OF ONE OF THE DEVICES TO MAKE SURE IT WOULD WORK PROPERLY BEFORE STARTING THE CASE, A GUIDE ROD GOT STUCK IN AN OIC HANDLE. AFTER MANY ATTEMPTS BY THE OR TECH AND SURGEON, IT WAS DETERMINED THAT THE GUIDE ROD WAS MALFUNCTIONING. A NEW GUIDE ROD AND OIC IM NAIL BASE SET WERE OPENED AND EVERYTHING WENT FINE AFTERWARD. DEVICE INFORMATION: GUIDE ROD IS OIC 3.0MM X 1000MM BALL TIP GUIDE ROD. STERILE PART # GW03-1000-S. LOT # 19-02005. THE HANDLE CAME FROM THE OIC IM NAIL BASE SET (YELLOW T-SHAPED HANDLE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1175767 | OIC INTRAMEDULLARY NAIL SYSTEM | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | HSB | ORTHOPAEDIC IMPLANT COMPANY, THE | GW03-1000-S | 19-02005 | 10811998036851 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |