CRANIOTOME BLADE, NEURO 1.8 X 29.2 MM
Received May 7, 2008
Report 1017294-2008-00197 · MDR key 1040675
Device
Generic name
Sterile Blade, Neuro
Manufacturer
Conmed LinvatecModel number
NACatalog number
C451
Lot number
BBD05884
Product problems
- Tear, Rip or Hole in Device Packaging
- Defective Device
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
REPORTER REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BLADE HAS A DEFORMITY. THE DEFORMITY NOTED IS A PIN HOLE IN THE PACKAGING TRAY. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BLADE AND PACKAGING FOR EVALUATION. DURING TESTING, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A PIN HOLE WAS NOTED IN THE TRAY CONTAINING THIS STERILE BLADE. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.