FDA Adverse Event
Malfunction
Summary report: N
LPC
MDR report key: 1566336
·
Received December 8, 2009
Report
- Report Number
- 1566336
- Event Type
- Malfunction
- Date Received
- December 8, 2009
- Date of Event
- November 17, 2009
- Report Date
- December 3, 2009
- Manufacturer
- SYNTHES, INC.
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA, US
Narratives
Description of Event or Problem · 1
SYNTHES DRILL BIT BROKE OFF IN PATIENT'S RIGHT HUMERUS AREA. DRILL BIT PIECE REMOVED USING C-ARM FOR ASSISTANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LPC | DRILL BIT, ORTHOPEDIC | HTW | SYNTHES, INC. | 310.25 | U109633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR |