FLEXIBLE DRILL SHAFT IC

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT BROKE DURING USE. THE PRODUCT IN QUESTION WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION AS IT WAS NOT RETURNED BY THE HOSPITAL. HOWEVER, A PICTURE OF THE DRILL SHAFT WAS PROVIDED WITH WHICH A LIMITED EXAMINATION CAN BE PERFORMED. IT CAN BE SEEN THAT THE FRACTURE OF THE DRILL SHAFT OCCURRED RIGHT AT THE START OF THE SPIRAL PART (BEGINNING FROM THE HEAD OF THE PRODUCT). IT IS KNOWN THAT THE MALFUNCTION OF THE DRILLING SHAFT OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH EFFECT ON THE PATIENT. ANOTHER DRILLING SHAFT WAS USED INSTEAD WHEN THE DRILL SHAFT BROKE TO FINISH THE SURGERY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE FLEXIBLE DRILLING SHAFT WERE CHECKED. THOSE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE DRILLING SHAFT WAS TWISTED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED 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 TWISTING OF THE 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: "THE DRILL SHAFT BEING USED DUE SURGERY TO DRILL HOLES FOR 6.5MM SCREWS IN PRS CUP. SURGEON WAS USING DRILL GUIDE AND REPORTED SHAFT BREAKING. ALL FRAGMENTS ACCOUNTED FOR DURING SURGERY.". 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.