BLADE TRITON 8MM GRAFT HARVEST
Received Oct 22, 2012 · Event occurred Sep 19, 2012
Report 1625507-2012-00102 · MDR key 2798173
Device
Generic name
Saw, Powered, And Accessories
Manufacturer
Mdt Powered Surgical SolutionsCatalog number
238GH1SS
Lot number
UNKNOWN
Product problems
- Packaging Problem
Patient
Not reported
- Injury
Narrative
Description of Event or Problem
IT WAS REPORTED THAT "THERE WAS AN INCIDENT TODAY (B)(6) WHERE DOCTOR ASKED FOR A 8MM AND ENDED UP TAKING A 6MM GRAFT NOT KNOWING. I DO NOT KNOW THE EXTENT THE PACKAGING PLAYED ON THIS BUT I DO KNOW THERE WAS CONFUSION AND HE HAD TO TAKE A SECOND GRAFT." NO PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE UPON FOLLOW UP.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
REPORT CONFIRMED. VISUAL EXAMINATION OF AN EXAMPLE OF THE PACKAGING DETERMINED THAT THE DESCRIPTION, CONTAINING THE SIZE OF THE BLADE, WAS NOT REFLECTED ON THE CURRENT PACKAGING. GCAPA (B)(4) WAS OPENED ON (B)(6) 2012 TO ADDRESS THIS ISSUE. INSTRUCTIONS INCLUDED IN DEVICE USER MANUAL STATES, "PRIOR TO EACH USE, THE ENTIRE TRITON" POWER SURGICAL INSTRUMENT SYSTEM MUST BE INSPECTED FOR PROPER OPERATION". WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE.