ULTRAPOWER BUR, ROUND END 3.2MM X 15.2MM

Description of Event or Problem

OUR FOREIGN DISTRIBUTOR REPORTED CONFIRMATION OF A CUSTOMER REPORT THAT THE BUR CAME LOOSE FROM THE CLAMSHELL AND HAD PIERCED A HOLE THROUGH THE PACKAGING, RESULTING IN COMPROMISE TO THE STERILITY OF THE PACKAGE. OUR DISTRIBUTOR ALSO REPORTED THAT THIS PROBLEM WAS NOTED BY THE CUSTOMER UPON OPENING THE BOX THAT CONTAINED THE STERILE PACKAGED BUR. THERE WAS NO PATIENT INVOLVEMENT, SERIOUS INJURY OR SURGICAL DELAY RELATED TO THIS EVENT.

Additional Manufacturer Narrative

INVESTIGATION FINDINGS: CONMED LINVATEC RECEIVED THIS BUR AND PACKAGING FOR EVALUATION. A VISUAL EXAMINATION OF THE PACKAGE CONFIRMED THE REPORTED EVENT. THE EVALUATOR FOUND THE BUR LOOSE FROM THE CLAMSHELL AND A HOLE PIERCED IN EACH END OF THE POUCH, WHICH RESULTED IN AN OBVIOUS BREACH TO STERILITY. AT THE TIME, THIS WAS CONSIDERED AN ISOLATED EVENT THAT WAS BLATANT; AND THEREFORE, NOT CONSIDERED A POTENTIAL TO CAUSE SERIOUS INJURY. FURTHER INVESTIGATION IN MAY 2008 INDICATES A TREND FOR THIS FAILURE MODE. BASED ON THIS NEW INFORMATION, THIS EVENT IS BEING REPORTED. AN INVESTIGATION REMAINS IN PROCESS FOR THIS FAILURE MODE. ASSOCIATED MDR: 1017294-2008-00222.