FLEXIBLE DRILL SHAFT IC

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT SNAPPED DURING USE. THE PRODUCT IN QUESTION WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION. SINCE NO PICTURES WERE PROVIDED EITHER, NO OPTICAL EXAMINATION CAN BE PERFORMED. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON PATIENTS, USERS, OR OTHERS. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE DRILL SHAFT AS WELL AS THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO DESIGN OR MANUFACTURING ERRORS COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED TO AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE DRILLING SHAFT. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. A FACTOR THAT MAY FAVOUR SUCH A FRACTURE OF THE DRILL SHAFT IS THE CONDITION OF THE BONE. SINCE THERE IS ALSO NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE INSTRUMENT BROKE DURING USE." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, IT HAD NO ADVERSE IMPACT ON THE PATIENT'S HEALTH AND DID NOT LEAD TO AN EXTENSION OF THE SURGERY TIME. IT IS NOT KNOWN, HOW THE PROCEDURE WAS SUCCESSFULLY COMPLETED.