BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DRILL SHAFT IC

    MDR report key: 23412453 · Received October 29, 2025

    Report

    Report Number
    3012523063-2025-00089
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 18, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT FRACTURED DURING USE. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE FRACTURE OF THE DRILL SHAFT OCCURRED AT THE JUNCTION BETWEEN THE SPIRAL PART AND THE STEM PART. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON PATIENTS, USERS, OR OTHERS. 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. 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 FRACTURE 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 "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT FRACTURED DURING USE. THE PRODUCT IN QUESTION WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION. HOWEVER, A PICTURE OF THE PRODUCT WAS PROVIDED. THE FRACTURE OF THE DRILL SHAFT OCCURRED AT THE JUNCTION BETWEEN THE SPIRAL PART AND THE STEM PART. IT IS KNOWN THAT THE INCIDENT HAPPENED INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON PATIENTS, USERS, OR OTHERS. 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. 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 FRACTURE 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 "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE FLEXIBLE DRILL SHAFT WAS BEING UTILIZED WITH A DRILL IN PLACE TO PREPARE A HOLE FOR A 6.5MM SCREW, WHICH WAS TO BE USED TO PROVIDE STABILITY IN A PRS CUP. AS THE SURGEON WAS DRILLING THE SHAFT SNAPPED/BROKE AT THE JUNCTION OF THE FLEXIBLE PORTION AND THE SOLID PART OF THE SHAFT." 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. FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 11/18/2025.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANT CAST GMBH: "THE FLEXIBLE DRILL SHAFT WAS BEING UTILIZED WITH A DRILL IN PLACE TO PREPARE A HOLE FOR A 6.5MM SCREW, WHICH WAS TO BE USED TO PROVIDE STABILITY IN A PRS CUP. AS THE SURGEON WAS DRILLING THE SHAFT SNAPPED/BROKE AT THE JUNCTION OF THE FLEXIBLE PORTION AND THE SOLID PART OF THE SHAFT." 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219164 FLEXIBLE DRILL SHAFT IC DRILL HTW IMPLANTCAST GMBH 02822120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other