FDA Adverse Event
Malfunction
Summary report: N
STRYKER INSTRUMENTS
MDR report key: 2663039
·
Received November 27, 2009
Report
- Report Number
- 2663039
- Event Type
- Malfunction
- Date Received
- November 27, 2009
- Date of Event
- November 1, 2009
- Report Date
- November 18, 2009
- Manufacturer
- STRYKER INSTRUMENTS, PRODUCT OF IRELAND
- Product Code
- DZJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HEAD TRAUMA. EMERGENCY SURGICAL CASE. A 1.5 WIRE PASS DRILL BIT TIP MISSING AFTER USE IN SURGERY. X-RAY TAKEN. FOREIGN OBJECT NOTED PER FILM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER INSTRUMENTS | 1.5MM WIRE PASS DRILL | DZJ | STRYKER INSTRUMENTS, PRODUCT OF IRELAND | 5820-103-15 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Other |