FLEXIBLE DRILL SHAFT IC

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT BROKE DURING USE. IT IS KNOWN THAT THE MALFUNCTION OF THE DRILLING SHAFT OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH EFFECT ON THE PATIENT, USERS OR THIRD PARTIES. ANOTHER DRILL SHAFT WAS USED INSTEAD WHEN THE DRILL SHAFT BROKE TO FINISH THE SURGERY. THE PRODUCT IN QUESTION WAS NOT RETURNED TO IMPLANTCAST GMBH AND NO LOT NUMBER WAS PROVIDED. AN OPTICAL EXAMINATION WAS THEREFORE NOT POSSIBLE AND THE MANUFACTURING DOCUMENTS AS WELL AS MATERIAL CERTIFICATES COULD NOT BE CHECKED FOR POSSIBLE FLAWS. 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 A FRACTURE OF THE DRILL SHAFT IS THE CONDITION OF THE BONE. SINCE THERE IS ALSO NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERNS "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "FLEXI DRILL SHAFT BROKE DURING USE. AN ALTERNATIVE WAS AVAILABLE AND USED TO COMPLETE THE SURGERY. NO EFFECT ON THE PATIENT OR DELAYS TO THE SURGERY WERE EXPERIENCED. " 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. ANOTHER DRILL SHAFT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.