inforMED
MalfunctionDWH

DUAL CUT SAGITTAL BLADE

Received Feb 22, 2010 · Event occurred Jul 29, 2009

Report 9616696-2010-00186 · MDR key 1625743

Device

Generic name

Saw Blades And Accessories

Catalog number

4111127090

Lot number

04121507

Product problems

  • Packaging Problem

Patient

UNK

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

IT CAN BE CONFIRMED FROM VISUAL INSPECTION THAT PRODUCT PACKAGING IS DAMAGED. OTHER COMPLAINTS HAVE BEEN RECEIVED REPORTING SIMILAR EVENTS. AN ALTERNATIVE PACKAGING MATERIAL HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT THE PRODUCT PACKAGING WAS BRITTLE. NO ADVERSE CONSEQUENCES WERE REPORTED.