BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR FOR CUP INSERT 36MM

    MDR report key: 19870221 · Received July 31, 2024

    Report

    Report Number
    3012523063-2024-00029
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 1, 2024
    Report Date
    July 31, 2024
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 07/01/2024, THE IMPLANTCAST GMBH RECEIVED THE FOLLOWING REPORT: "THREAD DEFECTIVE" THE SURGERY WAS COMPLETED BY USING ANOTHER IMPACTOR. NO MEDICAL RECORDS WERE PROVIDED REGARDING THE REPORTED INCIDENT. THE INCIDENT OCCURRED DURING IMPLANTATION. AFTER A REVIEW OF THE MANUFACTURING DOCUMENTS, A TECHNICAL CAUSE THAT COULD BE TRACED BACK TO MANUFACTURING PROBLEMS CAN BE RULED OUT. THE STANDARD SURGICAL TECHNIQUES AND THE INSTRUCTIONS FOR USE HAVE BEEN CHECKED IN TERMS OF CONTENT, NO ERRORS COULD BE FOUND. THE INCIDENT CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARD TO THE IMPACTOR. A POSSIBLE CAUSE FOR THE DEFECTIVE THREAD OF THE IMPACTOR COULD HAVE BEEN AN UNINTENTIONAL USER ERROR, HOWEVER IT WAS NOT REPORTED. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "UNSUITABLE THREADS" WITH THE CONSEQUENCE "INSTRUMENT FAILURE".

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THREAD DEFECTIVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886015 IMPACTOR FOR CUP INSERT 36MM IMPACTOR HWA IMPLANTCAST GMBH 02820009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other