inforMED
MalfunctionDWH

SAGITTAL BLADE

Received Feb 22, 2010 · Event occurred Jul 20, 2009

Report 9616696-2010-00176 · MDR key 1625711

Device

Generic name

Saw Blades And Accessories

Catalog number

2108218000

Lot number

09106027

Product problems

  • Device Packaging Compromised

Patient

UNK

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE BLADE EDGES HAD PERFORATED THE STERILE PACKAGING. NO ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THERE WERE A NUMBER OF ITEMS ASSOCIATED WITH THIS COMPLAINT. IT CAN BE CONFIRMED FROM VISUAL INSPECTION THAT PRODUCT PACKAGING IS DAMAGED. OTHER COMPLAINTS HAVE BEEN RECEIVED REPORTING SIMILAR EVENTS. A SECONDARY POLYBAG HAS BEEN INTRODUCED INTO THE PACKAGING CONFIGURATION OF THESE PRODUCTS TO ADDRESS THIS ISSUE.