inforMED
MalfunctionDWH

OSCILLATING AND SAGITTAL BLADE

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

Report 9616696-2010-00134 · MDR key 1625763

Device

Generic name

Saw Blades And Accessories

Catalog number

2296003111

Lot number

09028017

Product problems

  • Device Packaging Compromised

Patient

UNK

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT FOREIGN MATTER WAS OBSERVED ON THE OUTSIDE OF PRODUCT PACKAGING. NO ADVERSE CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

THE PRODUCT SUBJECT TO THIS COMPLAINT WAS RETURNED FOR EVALUATION. IT WAS VISUALLY CONFIRMED THAT FOREIGN MATTER WAS PRESENT WITHIN THE PRODUCT PACKAGE, BUT OUTSIDE THE STERILE COMPARTMENT OF THE BLADE. IT WAS NOT POSSIBLE TO DEFINITIVELY IDENTIFY THE FOREIGN SUBSTANCE.