CRANIOTOME BLADE, NEURO 1.8 X 29.2MM
Received May 7, 2008
Report 1017294-2008-00205 · MDR key 1040672
Device
Generic name
Sterile Blade, Neuro
Manufacturer
Conmed LinvatecModel number
NACatalog number
C451
Lot number
BBD15231
Product problems
- Hole In Material
- Device Packaging Compromised
- Material Deformation
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
OUR (B) (4) DISTRIBUTOR REPORTED THAT THE PACKAGING CONTAINING THIS STERILE NEURO BLADE HAS A DEFORMITY. THE DEFORMITY NOTED IS A PIN HOLE IN THE PACKAGING TRAY. THERE WAS NO PATIENT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BLADE AND PACKAGING FOR EVALUATION. DURING VISUAL INSPECTION, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A DEFORMITY WAS OBSERVED IN THE DISTAL CORNER OF THE BLISTER PACKAGING. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.