FLEXIBLE DRILL SHAFT IC

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "FLEXI DRILL SHAFT BROKE DURING USE - AN ALTERNATIVE WAS AVAILABLE AND USED TO COMPLETE THE SURGERY. NO EFFECT ON THE PATIENT OR DELAYS TO THE SURGERY WERE EXPERIENCED." 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. AN ALTERNATIVE PRODUCT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

Additional Manufacturer Narrative

ACCORDING TO THE EVENT DESCRIPTION, A FLEXIBLE DRILL SHAFT BENT DURING REGULAR USE. THE PRODUCT IN CONCERN HAS NOT BEEN SENT BACK TO IMPLANTCAST GMBH. A PHOTO OF THE BENT FLEXIBLE DRILL SHAFT WAS PROVIDED BY THE CUSTOMER, ENABLING A LIMITED OPTICAL EXAMINATION. SINCE NO LOT NUMBER WAS REPORTED, NEITHER MATERIAL CERTIFICATES NOR MANUFACTURING DOCUMENTS COULD BE CHECKED FOR POSSIBLE FLAWS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO TECHNICAL ROOT CAUSE OF THE DEFORMATION COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR. HOWEVER, THIS CAN NEITHER BE CONFIRMED NOR DENIED DUE TO A LACK OF INFORMATION. A FACTOR WHICH COULD FAVOUR DEFORMATIONS OF THE INSTRUMENT IS THE CONDITION OF THE BONE. SINCE THERE IS NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERNS "DEFORMATION OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.