FDA Adverse Event
Other
Summary report: N
*
MDR report key: 588525
·
Received March 29, 2005
Report
- Report Number
- 588525
- Event Type
- Other
- Date Received
- March 29, 2005
- Date of Event
- March 10, 2005
- Report Date
- March 21, 2005
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- LXZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
DURING A CABG, CORONAY ARTERY BYPASS GRAFT, SURGERY, THE SURGEON WAS USING A SAW WITH A SAW GUARD TO OPEN THE CHEST. THE SAW GUARD BROKE INTO PIECES. ALL PARTS WERE RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | STERNUM BLADE GUARD | LXZ | STRYKER INSTRUMENTS | 4107-8 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | NONE KNOWN. |