FDA Adverse Event
Malfunction
Summary report: N
SUREFIRE SCORPION NEEDLE
MDR report key: 1617153
·
Received January 15, 2010
Report
- Report Number
- 1617153
- Event Type
- Malfunction
- Date Received
- January 15, 2010
- Date of Event
- January 7, 2010
- Report Date
- January 15, 2010
- Manufacturer
- ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
TIP OF SUREFIRE SCORPION NEEDLE BROKE OFF INSIDE OF SOFT TISSUE OF PATIENT'S RIGHT SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUREFIRE SCORPION NEEDLE | NEEDLE, SUTURE | HWC | ARTHREX ARTHROSCOPY INSTRUMENTS, INC. | AR-13991N | 248915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |