BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DRILL SHAFT IC

    MDR report key: 24000663 · Received January 8, 2026

    Report

    Report Number
    3012523063-2025-00100
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 3, 2025
    Report Date
    January 8, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63153 FLEXIBLE DRILL SHAFT IC DRILL HTW IMPLANTCAST GMBH 02822120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other