ROUND BUR, LONG, CARBIDE 5MM
Received May 7, 2008
Report 1017294-2008-00198 · MDR key 1044786
Device
Generic name
Sterile Bur
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509223000
Lot number
BBD34676
Product problems
- Device Damaged Prior to Use
- Out-Of-Box Failure
- Tear, Rip or Hole in Device Packaging
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
OUR DISTRIBUTOR 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 EVAL. DURING VISUAL INSPECTION, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A DEFORMITY WAS OBSERVED IN THE PROXIMAL CORNER OF A BLISTER PACKAGING. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROGRESS.