ROUND BUR, MEDIUM, 2.4MM
Received May 7, 2008
Report 1017294-2008-00199 · MDR key 1040676
Device
Generic name
Sterile Bur
Manufacturer
Conmed LinvatecModel number
NACatalog number
00509122500
Lot number
BBD16202
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
UNK
- No Patient Involvement
Narrative
Description of Event or Problem
OUR DISTRIBUTOR REPORTED THAT THE PACKAGING CONTAINING THIS STERILE BUR 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 THE BLISTER PACKAGING. FURTHER INVESTIGATION FOUND THE PACKAGING TO BE COMPROMISED. AN INVESTIGATION FOR THIS FAILURE REMAINS IN PROCESS.