BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DRILL SHAFT IC

    MDR report key: 25120900 · Received May 8, 2026

    Report

    Report Number
    3012523063-2026-00026
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 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

    IMPLANTCAST GMBH RECEIVED A REPORT DESCRIBING THE BREAKAGE OF A FLEXIBLE DRILL SHAFT IC. THE SHAFT BROKE INTRAOPERATIVELY WHILE THE SURGEON WAS DRILLING THE HOLES NECESSARY FOR INSTALLING THE MUTARS® PRS SYSTEM, REPORTEDLY DUE TO THE ANGLE. THE AFFECTED FLEXIBLE DRILL SHAFT IC WAS DISCARDED BY THE HOSPITAL AND CONSEQUENTLY NOT AVAILABLE FOR AN OPTICAL EXAMINATION. HOWEVER, THE IMAGE OF THE AFFECTED FELXINBBLE DRILL SHAFT IC PROVIDED TO THE IMPLANTCAST GMBH CONFIRMED THE REPORTED INCIDENT. THE TIP OF THE FLEXIBLE DRILL SHAFT IC WAS BROKEN OFF AND THE SPIRAL PART WAS SLIGHTLY BENT. THIS ERROR PATTERN IS OFTEN OBSERVED WHEN THE FLEXIBLE DRILL SHAFT IC IS BENT AT AN ANGLE OF MORE THAN 45°. THE SURGICAL TECHNIQUE (ST) SPECIFICALLY PROHIBITS A BENDING OVER 45° AND EXCEEDING A MAXIMUM TORQUE OF 0.2 NM. IT ALSO STATES THAT NON-UNIFORM OR S-CURVE BENDING OF THE FLEXIBLE DRILL SHAFT IC DURING ITS APPLICATION REDUCES ITS LIFETIME. ACCORDING TO THE INCIDENT DESCRIPTION AND THE SALES REPRESENTATIVE WHO WAS PRESENT DURING THE PROCEDURE, THE SURGEON PERFORMING THE OPERATION EXCEEDED THE MAXIMUM BENDING ANGLE OF 45° WHILST DRILLING THE HOLE, WHICH RESULTED IN THE TIP OF THE FLEXIBLE DRILL SHAFT BREAKING OFF AS WELL AS THE SLIGHT DEFORMATION OF THE TWISTED PART DIRECTLY ABOVE THE BREAKAGE POINT. EXAMINATION OF THE MANUFACTURING DOCUMENTS WAS NOT POSSIBLE, AS THE LOT-NUMBER OF THE AFFECTED FLEXIBLE DRILL SHAFT IC IS UNKNOWN. FUNCTIONAL TESTING AND TESTING OF THE DIMENSIONAL ACCURACY COULD NOT BE PERFORMED, AS THE AFFECTED PRODUCT WAS NOT RETURNED TO IMPLANTCAST GMBH. AN EXAMINATION OF THE INSTRUCTIONS FOR USE (IFU) REVEALED NO DISCREPANCIES. BASED ON THE AVAILABLE INFORMATION, NO DESIGN OR MANUFACTURING ERROR COULD BE IDENTIFIED. THE MALFUNCTION MOST LIKELY OCCURRED AS A RESULT OF USER ERROR. THE DRILL SHAFT WAS BENT BEYOND THE MAXIMUM 45° ANGLE MENTIONED IN THE ST, RESULTING IN A BREAKAGE OF THE TIP AND THE DEFORMATION OF THE TWISTED PART ABOVE. AS ANOTHER FLEXIBLE DRILL SHAFT WAS AVAILABLE THIS INCIDENT HAD NO IMPACT ON THE PATIENT OR THE DURATION OF THE SURGERY. 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: "FLEXIBLE DRILL WAS USED FOR PRS TO DRILL HOLES AND SNAPPED OFF DUE TO THE ANGLE OF USE. SECOND CONTAINER ALSO HAD A FLEXIBLE DRILL IN SO THAT DRILL WAS USED TO FINISH CASE." PLEASE NOTE: THE EVENT OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE INFORMATION PROVIDED TO IMPLANTCAST GMBH, IT HAD NO IMPACT ON THE PATIENT OR THE DURATION OF THE SURGERY. ANOTHER IDENTICAL FLEXIBLE DRILL SHAFT IDENTICAL TO THE ORIGINAL ONE WAS AVAILABLE AND WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138471 FLEXIBLE DRILL SHAFT IC DRILL HTW IMPLANTCAST GMBH 02822120

    Patients

    Seq Age Sex Outcome Treatment
    1