FLEXIBLE BOHRWELLE IC

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT WAS DEFORMED DURING USE. THE PRODUCT IN QUESTION WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION. HOWEVER, A PICTURE OF THE PRODUCT WAS PROVIDED. THE BENDING OF THE DRILL SHAFT OCCURRED AT THE MIDSECTION OF THE SPIRAL PART. 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 COULD NOT BE CHECKED AS THE LOT-NUMBER WAS UNKNOWN. 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 BENDING 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 "DEFORMATION OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: " DRILL WAS USED FOR 2 DRILL HOLES AND BENT AND WOULD NOT RETURN TO CORRECT POSITION - PLEASE SEE IMAGE ALONGSIDE THIS REPORT. THIS OCCURRED WHEN DRILLING THE LAST DRILL HOLE AND WASN'T REQUIRED AGAIN. " 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. THE SURGERY WAS FINISHED WITH THE PRODUCT IN QUESTION.