BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS® UNI FEMORAL IMPACTOR

    MDR report key: 23411647 · Received October 29, 2025

    Report

    Report Number
    3012623063-2025-00091
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 29, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, A FEMORAL IMPACTOR BROKE DURING REGULAR USE. IT WAS REPORTED THAT THE EVENT HAPPENED INTRAOPERATIVELY. HOWEVER, IT IS UNKNOWN HOW EXACTLY THE SURGERY WAS FINISHED. NEITHER THE CONCERNED PRODUCT, NOR PHOTOS OF IT WERE PROVIDED BY THE CUSTOMER FOR FURTHER INVESTIGATION. BASED ON THE AVAILABLE INFORMATION, NO DESIGN OR MANUFACTURING ERRORS COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE EVENT CAN BE REGARDED TO AS A RANDOM FAILURE OF A COMPONENT. ACCORDING TO THE MANUFACTURING DOCUMENTS, THE PRODUCT HAS BEEN IN USE SINCE 2014. A POSSIBLE CAUSE FOR THE DEFECT COULD BE WEAKENING OF THE PSUR PART OF THE INSTRUMENT BY MULTIPLE STERILIZATION CYCLES WITH HIGH AND CHANGING TEMPERATURES, BEFORE ULTIMATELY BREAKING UNDER INFLUENCE OF A HIGH IMPACT FORCE DURING IMPLANTATION. HOWEVER, THIS ASSUMPTION CAN NEITHER BE CONFIRMED, NOR DENIED SINCE IT REMAINS UNKNOWN AT WHICH EXACT LOCATION THE INSTRUMENT BROKE. 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: "UNFORTUNATELY, 2 IMPACTORS BROKE DURING THE LAST OPERATION. PLEASE REPLACE THEM. " NOTE: IT IS KNOWN THAT THE EVENT OCCURRED INTRAOPERATIVELY. ACCORDING TO THE AVAILABLE INFORMATION, THE EVENT HAD NO ADVERSE IMPACT ON THE PATIENT'S HEALTH AND DID NOT LEAD TO A PROLONGATION OF SURGERY DURATION. THE AFFECTED PRODUCT WAS NOT SENT BACK TO IMPLANTCAST GMBH BY THE CUSTOMER AND IS THEREFORE NOT AVAILABLE FOR FURTHER INVESTIGATIONS. THE EXACT DATE OF THE EVENT WAS NOT REPORTED TO IMPLANTCAST GMBH BY THE CUSTOMER. IT IS THEREFORE ASSUMED THAT THE DATE OF THE EVENT CORRESPONDS WITH THE CLOCK START DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718928 ACS® UNI FEMORAL IMPACTOR IMPACTOR HWA IMPLANTCAST GMBH 42160506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other