BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTINIA® BROACH HANDLE EASY LOCK GIS® LEFT

    MDR report key: 23376813 · Received October 24, 2025

    Report

    Report Number
    3012523063-2025-00085
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K232371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A BROACH HANDLE CAME LOOSE FROM THE ATTACHED RASP WHEN TAPPING IT DURING REGULAR USE. IT WAS REPORTED THAT THE INCIDENT OCCURRED INTRAOPERATIVELY, AND THE DURATION OF THE SURGERY WAS EXTENDED BY 10 MINUTES. IT REMAINS UNCLEAR HOW EXACTLY THE SURGERY COULD BE FINISHED SINCE NO FURTHER INFORMATION WAS PROVIDED. THE AFFECTED PRODUCT WAS PROVIDED TO IMPLANTCAST GMBH ON 11/27/2025. DURING OPTICAL EXAMINATION OF THE HANDLE IT WAS NOTED THAT THE LOCKING MECHANISM VIA WHICH BROACHES CAN BE ATTACHED, IS OVERLY LOOSE. MANUFACTURING DOCUMENTS AND MATERIAL CERTIFICATES OF THE PRODUCT WERE CHECKED AND DID NOT DISPLAY ANY FLAWS. 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 BROACH HANDLE. A POSSIBLE ROOT CAUSE FOR THE LOOSENING OF THE LOCKING MECHANISM COULD BE APPLIED FORCES DURING REGULAR USE. THE PRODUCT WAS IN USE FOR OVER THREE YEARS. HOWEVER, HITS CAN NEITHER BE CONFIRMED NOR DENIED. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "ATTACHMENT DOES NOT FIT INSTRUMENT/IMPLANT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A BROACH HANDLE CAME LOOSE FROM THE ATTACHED RASP WHEN TAPPING IT DURING REGULAR USE. NEITHER THE CONCERNED PRODUCT, NOR PHOTOS OF IT WERE PROVIDED BY THE CUSTOMER FOR FURTHER INVESTIGATION. THE LOT NUMBER OF THE AFFECTED PRODUCT IS UNKNOWN. AN INSPECTION OF MANUFACTURING DOCUMENTS AND MATERIAL CERTIFICATES WAS THEREFORE NOT POSSIBLE. IT WAS REPORTED THAT THE INCIDENT OCCURRED INTRAOPERATIVELY, AND THE DURATION OF THE SURGERY WAS EXTENDED BY 10 MINUTES. IT REMAINS UNCLEAR HOW EXACTLY THE SURGERY COULD BE FINISHED SINCE NO FURTHER INFORMATION WAS PROVIDED. 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 BROACH HANDLE. DUE TO LACK OF INFORMATION, IT IS HARD DO DETERMINE A POSSIBLE ROOT CAUSE. IT IS POSSIBLE THAT THE LOCKING MECHANISM OF THE BROACH HANDLE MAY BE DEFECTIVE. HOWEVER, THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. SINCE THE LOT NUMBER IS UNKNOWN, IT CANNOT BE DETERMINED HOW LONG THE PRODUCT WAS IN USE. THE EVENT WAS ASSIGNED TO THE ERROR PATTERN "ATTACHMENT DOES NOT FIT INSTRUMENT/IMPLANT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE RASP HANDLE COMES LOOSE WHEN TAPPING THE RASP." NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G. WITH ANOTHER PRODUCT OR WITH THE PRODUCT IN QUESTION). THE LOT NUMBER OF THE AFFECTED PRODUCT IS UNKNOWN AS IT HAS NOT BEEN REPORTED BY THE REPORTING PERSON AND THE PRODUCT HAS NOT BEEN RETURNED TO IMPLANTCAST GMBH. FOLLOW-UP: THE AFFECTED PRODUCT WAS PROVIDED TO IMPLANTCAST GMBH ON 11/27/2025.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE RASP HANDLE COMES LOOSE WHEN TAPPING THE RASP." NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY AND THAT IT CAUSED A PROLONGATION OF THE SURGERY OF 10 MINUTES. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G. WITH ANOTHER PRODUCT OR WITH THE PRODUCT IN QUESTION). THE LOT NUMBER OF THE AFFECTED PRODUCT IS UNKNOWN AS IT HAS NOT BEEN REPORTED BY THE REPORTING PERSON AND THE PRODUCT HAS NOT BEEN RETURNED TO IMPLANTCAST GMBH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241944 ACTINIA® BROACH HANDLE EASY LOCK GIS® LEFT HANDLE LZO IMPLANTCAST GMBH 80049135

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other