BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACS® UNI FEMORAL IMPACTOR - PART 2

    MDR report key: 21846424 · Received April 16, 2025

    Report

    Report Number
    3012523063-2025-00039
    Event Type
    Malfunction
    Date Received
    April 16, 2025
    Date of Event
    March 24, 2025
    Report Date
    April 16, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, AN ACS® UNI FEMORAL IMPACTOR BROKE DURING USE. THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR AN OPTICAL EXAMINATION. HOWEVER, A PICTURE OF THE PRODUCT WAS PROVIDED, WITH WHICH A LIMITED OPTICAL EXAMINATION COULD BE CARRIED OUT. A PIECE OF THE PPSU PART IS BROKEN OFF, REVEALING THE THREADING BELOW IT. IT IS KNOWN THAT THE FRACTURE OCCURRED INTRAOPERATIVELY. IT IS NOT KNOWN WHETHER THERE WERE ANY HEALTH EFFECTS ON THE PATIENT OR HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF ANOTHER PRODUCT WAS AVAILABLE OR IF THE SURGERY WAS FINISHED WITH THE PRODUCT IN QUESTION). THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE FEMORAL IMPACTOR WERE CHECKED. THESE DID NOT REVEAL ANY ERRORS. THE SURGICAL TECHNIQUES AND INSTRUCTIONS FOR USE WERE ALSO 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 FEMORAL IMPACTOR. A POTENTIAL CAUSE COULD BE AN UNINTENTIONAL USER ERROR, BUT THIS CANNOT BE CONFIRMED OR DENIED DUE TO A LACK OF INFORMATION. THE PRODUCT IN QUESTION IS IN USE FOR OVER 10 YEARS, THEREFORE IT IS SAFE TO SAY THAT THE IMPACTOR HAD TO WITHSTAND SEVERAL FORCES/ IMPACT PROCESSES. 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: "IN TODAY'S MORNING, ONE OF OUR DISTRIBUTOR DURING THE A SURGERY REPORTED TO ME THAT A PIECE OF AN INSTRUMENTARIUM BROKE OFF, AS THE ATTACHED PHOTO." NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF ANOTHER PRODUCT WAS AVAILABLE OR IF THE SURGERY WAS FINISHED WITH THE PRODUCT IN QUESTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440213 ACS® UNI FEMORAL IMPACTOR - PART 2 IMPACTOR HWA IMPLANTCAST GMBH 4216050602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other ACS® UNI FEMORAL IMPACTOR 42160506 1415INI01B