FLEXIBLE DRILL SHAFT 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 SPIRAL PART IS DEFORMED/ TWISTED RIGHT AT THE START (BEGINNING FROM THE STEM PART OF THE PRODUCT). THE SPIRAL PART IS BENT IN AN ANGLE OF ABOUT 130°. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. AN ALTERNATIVE PRODUCT WAS USED INSTEAD WITH WHICH THE SURGERY COULD BE FINISHED SUCCESSFULLY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE DRILL SHAFT WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. IN THE SURGICAL TECHNIQUE IS DESCRIBED THAT THE FLEXIBLE DRILL SHAFT CAN BE BENT UP TO MAXIMUM OF 45 DEGREES. IF THE FLEXIBLE DRILL SHAFT IS BENT ANY FURTHER THE LIFETIME OF THE PRODUCT CAN BE REDUCED. 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. THE DRILL SHAFT HAS BEEN BENT OVER THE MAXIMUM ANGLE OF 45 DEGREES MENTIONED IN THE INSTRUCTIONS FOR USE AT SOME POINT. A FACTOR THAT MAY FAVOUR SUCH A DEFORMATION AND/ OR BREAKAGE 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 IMPLANT CAST GMBH: "FLEXIBLE DRILL SHAFT BROKE DURING INTRAOPERATIVE USE. NO FURTHER DETAILS ARE AVAILABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DRILL SHAFT." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. AN ALTERNATIVE PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ON THE PROVIDED PICTURE CAN BE SEEN, THAT THE DRILL SHAFT IS NOT BROKEN BUT RATHER DEFORMED/ TWISTED.

Additional Manufacturer Narrative

ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT WAS DEFORMED DURING USE. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE SPIRAL PART IS DEFORMED/ TWISTED RIGHT AT THE START (BEGINNING FROM THE STEM PART OF THE PRODUCT). THE SPIRAL PART IS BENT IN AN ANGLE OF ABOUT 130°. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. AN ALTERNATIVE PRODUCT WAS USED INSTEAD WITH WHICH THE SURGERY COULD BE FINISHED SUCCESSFULLY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE DRILL SHAFT WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. IN THE SURGICAL TECHNIQUE IS DESCRIBED THAT THE FLEXIBLE DRILL SHAFT CAN BE BENT UP TO MAXIMUM OF 45 DEGREES. IF THE FLEXIBLE DRILL SHAFT IS BENT ANY FURTHER THE LIFETIME OF THE PRODUCT CAN BE REDUCED. 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. THE DRILL SHAFT HAS BEEN BENT OVER THE MAXIMUM ANGLE OF 45 DEGREES MENTIONED IN THE INSTRUCTIONS FOR USE AT SOME POINT. A FACTOR THAT MAY FAVOUR SUCH A DEFORMATION AND/ OR BREAKAGE 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: "FLEXIBLE DRILL SHAFT BROKE DURING INTRAOPERATIVE USE. NO FURTHER DETAILS ARE AVAILABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DRILL SHAFT." NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. AN ALTERNATIVE PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ON THE PROVIDED PICTURE CAN BE SEEN, THAT THE DRILL SHAFT IS NOT BROKEN BUT RATHER DEFORMED/ TWISTED. FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 02/27/2025.