MalfunctionDWH
OSTEOSTAT STERNAL SAW
Received Feb 22, 1997 · Event occurred Dec 1, 1996
Report 1646654-1997-00001 · MDR key 71775
Device
Generic name
Instrument, Sternum Saw
Manufacturer
Surgiquip, Inc.Model number
NACatalog number
100-0011
Lot number
0596SHP01
Patient
UNKNOWN
Narrative
Description of Event or Problem
A DECEASED PT WAS UNDERGOING AN ORGAN-DONOR PROCEDURE IN WHICH THE STERNUM SAW WAS USED. DURING THE PROCEDURE, THE BLADE PROTECTOR BROKE OFF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE AND THERE WAS NO FURTHER INCIDENT. THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.