FDA Adverse Event
Malfunction
Summary report: N
SUREFIRE SCORPION NEEDLE
MDR report key: 1247503
·
Received November 25, 2008
Report
- Report Number
- 1247503
- Event Type
- Malfunction
- Date Received
- November 25, 2008
- Date of Event
- November 12, 2008
- Report Date
- November 25, 2008
- Manufacturer
- ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
- Product Code
- MFJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
SURGEON WAS USING THE NEEDLE AND THE TIP BROKE. THE TIP WAS RETRIEVED BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SUREFIRE SCORPION NEEDLE | NEEDLE, SUTURING | MFJ | ARTHREX ARTHROSCOPY INSTRUMENTS, INC. | AR-13991N | 178935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |