X-LONG ROUND CARBIDE BUR
Received Apr 2, 2008 · Event occurred Feb 12, 2008
Report 1017294-2008-00175 · MDR key 1025676
Device
Generic name
Sterile Bur
Manufacturer
Conmed LinvatecModel number
NACatalog number
X50R
Lot number
BBD18238
Product problems
- Device Damaged Prior to Use
- Tear, Rip or Hole in Device Packaging
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
REPORTER REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BUR IS DAMAGED. THERE WAS NO PT INVOLVEMENT, INJURY OR SURGICAL DELAY RESULTING FROM THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR AND PACKAGING FOR EVAL. DURING TESTING, CONMED LINVATEC CONFIRMED THE REPORTED PROBLEM. A DEFORMITY WAS NOTED IN THE DISTAL CORNER OF THE BLISTER PACKAGING CONTAINING THIS STERILE BUR. FURTHER INVESTIGATION FOUND THE PACKAGING COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.