BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR FOR CUP INSERT 36MM

    MDR report key: 21320998 · Received February 6, 2025

    Report

    Report Number
    3012523063-2025-00018
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 13, 2025
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    HWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, AN IMPACTOR FOR CUP INSERTS BROKE DURING USE. THE PRODUCT IN QUESTION WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE WHOLE PRODUCT FRACTURED AND IS SPLIT INTO TWO PARTS. IT IS KNOWN THAT THE ISSUE OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THIS MALFUNCTION HAD NO HEALTH EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED INSTEAD TO FINISH THE SURGERY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE IMPACTOR FOR CUP INSERT 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 TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE ISSUE OCCURRED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE IMPACTOR FOR CUP INSERT. THE PRODUCT IN QUESTION WAS MANUFACTURED IN AUGUST 2013 AND IS THEREFORE IN USE FOR 11.5 YEARS. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DESCRIPTION OF THE EVENT, AN IMPACTOR FOR CUP INSERTS BROKE DURING USE. THE PRODUCT IN QUESTION WAS NOT SUBJECTED TO AN OPTICAL EXAMINATION. SINCE THERE ARE ALSO NO PICTURES AVAILABLE, NO OPTICAL EXAMINATION COULD BE PERFORMED. BASED ON THE DESCRIPTION OF THE EVENT THE IMPACTOR FOR CUP INSERT BROKE DURING USE. IT IS KNOWN THAT THE ISSUE OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THIS MALFUNCTION HAD NO HEALTH EFFECT ON THE PATIENT. ANOTHER PRODUCT WAS USED INSTEAD TO FINISH THE SURGERY. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE IMPACTOR FOR CUP INSERT 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 TECHNICAL ROOT CAUSE COULD BE DETERMINED WHY THE ISSUE OCCURRED. IT CAN ONLY BE ASSUMED THAT THE MALFUNCTION CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE IMPACTOR FOR CUP INSERT. THE PRODUCT IN QUESTION WAS MANUFACTURED IN AUGUST 2013 AND IS THEREFORE IN USE FOR 11.5 YEARS. 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 IMPLANT CAST GMBH: "BROKEN DURING USE". NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY. FOLLOW-UP: IMPLANT CAST GMBH WAS PROVIDED WITH THE AFFECTED PRODUCT ON 02/13/2025.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "BROKEN DURING USE". NOTE: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NO HEALTH IMPACT ON THE PATIENT. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298572 IMPACTOR FOR CUP INSERT 36MM IMPACTOR HWA IMPLANTCAST GMBH 02820009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other