inforMED
InjuryDWH

SYSTEM 2000 STERNUM SAW

Received Jul 3, 1997

Report 1811755-1997-00059 · MDR key 103141

Device

Generic name

Saw

Model number

2107-000-000

Catalog number

NA

Lot number

NA

Product problems

Patient

UNKNOWN

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

CHIEF OF CARDIAC SURGERY WAS EVALUATING REPS/REGIONS SAMPLE EQUIPMENT. SAW POWERED UP, WORKED FINE, THEN STALLED. DR ALLEGES SAW SHREDDED STERNUM WHICH REQUIRED BASKET WEAVING THE STERNUM BACK TOGETHER USING WIRES. REP PULLED 4 SAMPLE SAWS AND 2 SAMPLE CHARGERS, BEING RETURNED.