ULTRAPOWER BUR, ROUND 2 MM
Received May 29, 2008 · Event occurred May 28, 2008
Report 1017294-2008-00220 · MDR key 1054437
Device
Product problems
- Loose
- Out-Of-Box Failure
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
DURING RECEIVING AND INSPECTION OF THIS BUR AND PACKAGING, OUR DISTRIBUTOR NOTED (2008) THAT THE BUR WAS LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. THE DISTRIBUTOR ALSO REPORTED THAT THE BUR DID NOT BREAK THROUGH THE STERILE PACKAGING.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR AND PACKAGING FOR EVAL. DURING A VISUAL EXAMINATION OF THE PACKAGE, THE EVALUATOR FOUND THE BUR LOOSE FROM THE CLAMSHELL AND SCRATCHES ON THE INSIDE OF THE POUCH. DURING FURTHER INVESTIGATION ON MAY 28, 2008, THE EVALUATOR CONCLUDED THROUGH TESTING THAT THE STERILITY OF THE PACKAGE WAS COMPROMISED. AN INVESTIGATION REMAINS IN PROCESS FOR THIS FAILURE MODE.