DRILL CS 7.5

Description of Event or Problem

THE HOLLOW DRILL BROKE DURING AN OPERATION AT THE LLISOSACRAL JOINT. WHILE DRILLING THE BONE ABOVE THE K-WIRE, THE HOLLOW DRILL TWISTED AND BURST IN MANY BIGGER AND SMALLER PIECES. FRAGMENTS OF THE DRILL FLEW INTO THE OPEN WOUND OF THE PATIENT AND HAD TO BE REMOVED. THEREFOR THE WOUND HAD TO BE ENLARGED AND THE DURATION OF THE OPERATION HAD TO BE EXTENDED.

Additional Manufacturer Narrative

THE DRILL AFFECTED BY THE INCIDENT COULD NOT BE PROVIDED TO THE MANUFACTURER FOR DETAILED ANALYSIS. HOWEVER, THE MANUFACTURER WAS PROVIDED WITH THE ARTICLE AND LOT NUMBER, ON THE BASIS OF WHICH AN ANALYSIS OF PARTS FROM THE SAME BATCH WAS CARRIED OUT. IN ADDITION, THE ENTIRE MANUFACTURING CHAIN FROM RAW MATERIAL TO FINISHED PRODUCT WAS ANALYZED AND EVALUATED. NEITHER THE PARTS FROM THE SAME BATCH NOR THE PRODUCTION DOCUMENTATION SHOWED ANY DEVIATIONS FROM THE SPECIFICATION THAT COULD HAVE LED TO SUCH A FAILURE. ALSO IN THE COMPLAINT STATISTICS NO SIMILAR FAILURE CASE COULD BE FOUND. IN SUMMARY, IT CAN BE STATED THAT THIS IS AN INDIVIDUAL CASE, THE EXACT CAUSE OF WHICH CANNOT BE ANALYZED FURTHER DUE TO THE ABSENCE OF THE FAILED COMPONENT. THIS IS A LATE REPORT DUE TO A CORRECTIVE ACTION.