FLEXIBLE DRILL SHAFT IC

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "WHILST USING THE FLEXIBLE DRILL SHAFT, THE DRILL BIT GOT STUCK ON A BIT OF BONE AND THIS CAUSED THE FLEXIBLE DRILL SHAFT TO SNAP." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. ACCORDING TO THE AVAILABLE INFORMATION, THE EVENT HAD NO ADVERSE IMPACT ON THE PATIENT'S HEALTH AND DID NOT LEAD TO A PROLONGATION OF SURGERY DURATION. THE LOT-NUMBER OF THE AFFECTED PRODUCT IS UNKNOWN AS IT WAS NOT REPORTED BY THE REPORTING PERSON. THE AFFECTED PRODUCT WAS DISPOSED BY THE HOSPITAL AND WILL THEREFORE NOT BE SENT BACK FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT BROKE DURING USE. NEITHER THE CONCERNED PRODUCT, NOR PHOTOS OF IT WERE PROVIDED BY THE CUSTOMER FOR FURTHER INVESTIGATION. THE LOT NUMBER OF THE AFFECTED PRODUCT IS UNKNOWN. AN INSPECTION OF MANUFACTURING DOCUMENTS AND MATERIAL CERTIFICATES WAS THEREFORE NOT POSSIBLE. 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 DEFORMATION OF THE DRILL SHAFT IS THE CONDITION OF THE BONE. SINCE THERE IS ALSO NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. IT WAS REPORTED THAT THE INCIDENT WITH THE DRILLING SHAFT OCCURRED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON THE PATIENT. THE SURGERY WAS SUCCESSFULLY FINISHED BY USING AN ALTERNATIVE PRODUCT. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.