FDA Adverse Event
Malfunction
Summary report: N
STRYKER INSTRUMENTS
MDR report key: 680636
·
Received February 8, 2006
Report
- Report Number
- MW1037969
- Event Type
- Malfunction
- Date Received
- February 8, 2006
- Date of Event
- January 25, 2006
- Report Date
- January 30, 2006
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- JDZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE PREPARING BONE CEMENT IN STRYKER MIXING BOWLS, HANDLE WAS BROKEN AND RPTR WAS UNABLE TO MIX BONE CEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER INSTRUMENTS | HIGH VACUUM MIXING BOWL | JDZ | STRYKER INSTRUMENTS | * | 05305012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |