FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3844697
·
Received May 29, 2014
Report
- Report Number
- 3844697
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- May 2, 2014
- Report Date
- May 29, 2014
- Manufacturer
- SYNTHES (USA) PRODUCTS LLC
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
IN ATTEMPTING TO REMOVE A STRANGULATED SCREW THE TIP OF A SCREW DRIVER BROKE OFF INTO SCREW HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317300 | * | SCREWDRIVER | HXX | SYNTHES (USA) PRODUCTS LLC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |