BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DRILL SHAFT IC

    MDR report key: 23904740 · Received December 29, 2025

    Report

    Report Number
    3012523063-2025-00099
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 29, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT WAS FRACTURED INTRAOPERATIVELY DURING USE. THE AFFECTED DRILL SHAFT WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE SPIRAL PART OF THE FLEXIBLE DRILL SHAFT IS TWISTED. IT IS KNOWN THAT THE MALFUNCTION OF THE DRILLING SHAFT OCCURRED DURING USE/ INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF ABOUT 10 MINUTES. HOWEVER, THIS HAD NO HEALTH EFFECT ON THE PATIENT. ANOTHER DRILLING SHAFT WAS USED INSTEAD WHEN THE DRILL SHAFT BROKE TO FINISH THE SURGERY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE FLEXIBLE DRILLING SHAFT WERE CHECKED. THOSE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE CHECKED AND SHOWED NO DEVIATIONS. BASED ON THE AVAILABLE INFORMATION, NO TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE DRILLING SHAFT WAS TWISTED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED 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 TWISTING OF THE SHAFT IS THE CONDITION OF THE BONE. SINCE THERE IS ALSO NO INFORMATION AVAILABLE, NO STATEMENT IS POSSIBLE. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERNS "DEFORMATION 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 FRACTURED INTRAOPERATIVELY DESPITE PROPER USE. IT WAS NECESSARY TO CONTINUE THE PROCEDURE WITH A REPLACEMENT INSTRUMENT FROM DEPUY, WHICH RESULTED IN AN OVERALL EXTENSION OF THE OPERATING TIME BY 10 MINUTES. " NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED AN EXTENSION OF THE SURGERY TIME OF ABOUT 10 MINUTES. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS EXTENSION HAD NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY. IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 12/16/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790168 FLEXIBLE DRILL SHAFT IC DRILL HTW IMPLANTCAST GMBH 02822120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other