inforMED
MalfunctionDWH

OSTEOSTAT STERNAL SAW

Received Mar 7, 1997 · Event occurred Feb 5, 1997

Report 2219689-1997-00151 · MDR key 74806

Device

Generic name

Instrument

Manufacturer

Surgiquip, Inc.

Model number

NA

Catalog number

4100-0-011

Lot number

0696SHP01

Patient

NA

Narrative

Description of Event or Problem

THE SAW WAS NOT STERILE UPON OPENING. THIS EVENT OCCURRED PRIOR TO SURGERY, THEREFORE, THERE WAS NO PT INVOLVEMENT.