ULTRAPOWER BUR, ROUND MUSTARD 2.0 MM
Received Aug 21, 2009 · Event occurred Jun 29, 2009
Report 1017294-2009-00118 · MDR key 1494046
Device
Generic name
Instrument, Surg, Orthopedic, Pneumatic
Manufacturer
Conmed LinvatecModel number
NACatalog number
00702122400
Lot number
BBD32569
Product problems
- Device Slipped
Patient
NA
- No Information
Narrative
Description of Event or Problem
OUR (B) (6) 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. AN EVAL CONFIRMED THAT THE BUR WERE NOT RETAINED IN THE INNER CLAMSHELL, RESULTING IN SCRATCH MARKS ON THE PACKAGING, WHICH HAS THE POTENTIAL TO COMPROMISE THE PRODUCT STERILITY.