SAGITTAL BLADE
Received Mar 25, 2010 · Event occurred Feb 22, 2010
Report 9616696-2010-00213 · MDR key 1648730
Device
Generic name
Saw Blades And Accessories
Manufacturer
Stryker Ireland, Ltd.Catalog number
2108110000
Lot number
07225017
Product problems
- Tear, Rip or Hole in Device Packaging
- Difficult to Open or Remove Packaging Material
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PACKAGING OF PRODUCT (B)(4) WAS TEARING WHILE OPENING THE PRODUCT WHICH CAUSED TWO BLADES TO BECOME UNSTERILE POTENTIALLY CONTAMINATING THE STERILE FIELD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRD BLADE. NO ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
THERE WERE TWO LOT NUMBERS ASSOCIATED WITH THIS COMPLAINT (B)(4) . THE PRODUCT HAS NOT YET BEEN RETURNED FOR EVALUATION. BASED ON THE INFO PROVIDED BY THE SALES REP, IT CAN BE ASSUMED THAT PRODUCT PACKAGING ASSOCIATED WITH THIS EVENT IS DAMAGED. AN ALTERNATIVE PACKAGING MATERIAL HAS BEEN IMPLEMENTED TO ADDRESS THIS ISSUE.