STERNUM SAW BLADE GUARD
Received Jan 11, 2007 · Event occurred Dec 13, 2006
Report 1017294-2006-00613 · MDR key 809100
Device
Generic name
Blade Guard
Manufacturer
Conmed LinvatecModel number
NACatalog number
00505900600
Lot number
P-04-98
Product problems
- Break
- Component Falling
- Replace
Patient
51 YR
- Foreign body, removal of
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THIS BLADE GUARD, IT BROKE AND FELL INTO THE SURGICAL SITE. THE BROKEN PORTION WAS RETRIEVED AND AN ALTERNATE BLADE GUARD WAS USED. THERE WAS NO PT INJURY NOR DELAY RELATED TO THIS EVENT.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: THE PRODUCT WAS RECEIVED FOR EVAL AND THE REPORTED PROBLEM WAS CONFIRMED. A VISUAL INSPECTION OF THE DEVICE FOUND THAT THE SHAFT WAS BROKEN. THIS DAMAGE CAN OCCUR, AS THE SHAFT OF THE STERNUM GUARD CAN BECOME DAMAGED/BENT OVERTIME FROM HANDLING/USE. A REVIEW OF PRODUCT HISTORY FOR THE PAST 2 YEARS FOUND NO OTHER REPORTED EVENTS FOR THIS FAILURE MODE. CONMED LINVATEC WILL CONTINUE TO MONITOR THIS PRODUCT FOR FAILURES.