ULTRAPOWER BUR, ROUND 2MM
Received Jun 3, 2008 · Event occurred Apr 28, 2008
Report 1017294-2008-00227 · MDR key 1056019
Device
Product problems
- Loose
- Out-Of-Box Failure
Patient
NA
- No Patient Involvement
Narrative
Description of Event or Problem
OUR JAPAN DISTRIBUTOR REPORTED THAT DURING RECEIVING AND INSPECTION OF THIS DEVICE, THEY FOUND THE BUR CAME LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. THE DISTRIBUTOR DID NOT REPORT ANY COMPROMISE TO THE STERILITY OF THE PACKAGE.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR AND PACKAGING FOR EVAL. IN 2008, A VISUAL EXAMINATION OF THE PACKAGE CONFIRMED THE REPORT THAT THE BUR IS LOOSE FROM THE CLAMSHELL INSIDE THE STERILE PACKAGING. FURTHER INVESTIGATION FOUND SCRATCHES ON THE POUCH AND CONFIRMED A COMPROMISE TO THE STERILITY OF THE PACKAGING, MAKING THIS A POTENTIAL FOR INJURY AND A REPORTABLE EVENT. AN INVESTIGATION FOR THIS FAILURE MODE REMAINS IN PROCESS.