MalfunctionDWH
COLLINS RADIOPARENT BLADE
Received Mar 12, 2012 · Event occurred Feb 12, 2012
Report 1226348-2012-00126 · MDR key 2488506
Device
Generic name
Blade, Saw, Surgical, Cardiovascular
Manufacturer
Codman And Shurtleff - RaynhamCatalog number
50-8081
Lot number
123831
Product problems
- Break
- Other (for use when an appropriate device code cannot be identified)
Patient
NA · Unknown
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
AFFILIATE REPORTED THAT THE WHEN THE BLADES WERE INSERTED INTO THE RETRACTOR BODY AND SPREAD WITH MINOR FORCE, ONE OF THE TWO BLADES BROKE IN PIECES, THE STERNUM CLOSED SUDDENLY. AFFILIATE ALSO REPORTED THE TEXTURE OF THE BLADES APPEARED TO BE DIFFERENT.
Additional Manufacturer Narrative
UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.