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 IS AVAILABLE FOR AN OPTICAL EXAMINATION. 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 ISSUES WITH THE DRILLING SHAFT OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT 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. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE PRODUCT COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS OF THE DRILLING SHAFT. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO LACK OF INFORMATION. A FACTOR THAT MAY FAVOUR SUCH A BREAKAGE 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 PATTERN "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 BROKE DURING SURGERY DESPITE BEING USED CORRECTLY. " NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NEITHER A HEALTH IMPACT ON THE PATIENT NOR AN EXTENSION OF THE SURGERY TIME AS CONSEQUENCE. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY.