BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL/TIBIAL EXTRACTOR

    MDR report key: 24909484 · Received April 17, 2026

    Report

    Report Number
    3012523063-2026-00023
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 17, 2026
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, AN EXTRACTOR WAS DEFORMED AT THE TIP DURING USE. THE PRODUCT IN QUESTION WAS SENT TO IMPLANTCAST GMBH FOR OPTICAL INVESTIGATION AND THE DEFORMED TIP WAS EVIDENT. IT IS KNOWN THAT THE DEFORMATION OF THE EXTRACTOR OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THIS HAD NO HEALTH EFFECT ON THE PATIENT. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE EXTRACTOR 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 FAILURE OF THE DESIGN OR DURING THE MANUFACTURING OF THE PRODUCT COULD BE DETERMINED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE EXTRACTOR. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "DEFORMATION OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "MECHANICALLY DAMAGED". NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NO HEALTH IMPACTS ON PATIENTS, USERS OR THIRD PARTIES RELATING TO THE REPORTED ERROR PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345625 FEMORAL/TIBIAL EXTRACTOR EXTRACTOR HWB IMPLANTCAST GMBH 42230036

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention