BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE DRILL SHAFT IC

    MDR report key: 21477130 · Received February 27, 2025

    Report

    Report Number
    3012523063-2025-00023
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 8, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A FLEXIBLE DRILL SHAFT BROKE OFF DURING USE. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE FRACTURE OCCURRED RIGHT AT THE START OF THE SPIRAL PART, BEGINNING FROM THE HEAD OF THE PRODUCT. IT IS KNOWN THAT THE FRACTURE OF THE DRILLING SHAFT OCCURRED DURING USE / INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT 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. 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 TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE DRILLING SHAFT BROKE. 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 BREAKAGE 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 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 BROKE OFF DURING USE. THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR AN OPTICAL EXAMINATION. HOWEVER, A PICTURE OF THE DRILL SHAFT WAS PROVIDED. THE FRACTURE OF THE DRILL SHAFT OCCURRED AT THE END OF THE SPIRAL PART, BEGINNING FROM THE HEAD. IT IS KNOWN THAT THE FRACTURE OF THE DRILLING SHAFT OCCURRED DURING USE / INTRAOPERATIVELY. HOWEVER, THERE WAS NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT 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. 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 TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE DRILLING SHAFT BROKE. 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 BREAKAGE 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 PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DRILL SHAFT BREAKS AGAIN IN THE CLINIC AFTER A SINGLE USE. THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE ARE OTHER DRILL SHAFTS IN THE HOUSE (COMPETITOR)". NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NEITHER A HEALTH IMPACT ON THE PATIENT NOR AN EXTENSION OF THE SURGERY TIME AS CONSEQUENCE. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY. FOLLOW-UP: IMPLANTCAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 04/08/2025.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DRILL SHAFT BREAKS AGAIN IN THE CLINIC AFTER A SINGLE USE. THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE ARE OTHER DRILL SHAFTS IN THE HOUSE (COMPETITOR)." NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NEITHER A HEALTH IMPACT ON THE PATIENT NOR AN EXTENSION OF THE SURGERY TIME AS CONSEQUENCE. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027508 FLEXIBLE DRILL SHAFT IC DRILL HTW IMPLANTCAST GMBH 02822120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other