FLEXIBLE DRILL SHAFT IC

Description of Event or Problem

THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "UNFORTUNATELY, THIS HAPPENED WHEN I START TO DO AN EXTRA FIXATION OF THE ACETABULAR SHELL AND WHEN I JUST STARTED TO REAM UNFORTUNATELY IT'S BROKEN" A TOTAL OF THREE INSTRUMENTS ARE BROKEN: A FLEXIBLE DRILL SHAFT AND TWO DRILLS (40MM AND 60MM). IT IS NOT KNOWN WHETHER THE THREE INSTRUMENTS BROKE DURING THE SAME SURGERY. SINCE THREE INSTRUMENTS ARE AFFECTED, THIS CASE WAS SPLIT AS FOLLOWS: : FLEXIBLE DRILL SHAFT IC 3012523063-2026-00005: DRILL Ø 3,2/40MM WITH DEPTH MARKING 3012523063-2026-00006: DRILL Ø 3,2/60MM WITH DEPTH MARKING. 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 DESCRIPTION OF THE EVENT, A DRILL SHAFT AND TWO DRILLS BROKE OFF DURING USE. THE PRODUCTS IN QUESTION WERE SUBJECTED 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). THE FRACTURE OF THE Ø 3.2/60 MM DRILL OCCURRED IN THE FIRST THIRD OF ITS LENGTH AND THE FRACTURE OF THE Ø 3.2/40 MM DRILL IN THE LAST THIRD OF ITS LENGTH (BEGINNING FROM THE TIP). IT IS KNOWN THAT THE FRACTURE OF THE PRODUCTS OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THIS HAD NO HEALTH EFFECT ON THE PATIENT, AS OTHER PRODUCTS WERE USED INSTEAD. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE PRODUCTS 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 PRODUCTS COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTIONS CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE PRODUCTS. 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 BREAKAGE OF THE PRODUCTS IS THE CONDITION OF THE BONE. SINCE THERE IS ALSO NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. THESE EVENTS WERE ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.