BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR FOR CUP INSERT 32MM

    MDR report key: 20200198 · Received September 12, 2024

    Report

    Report Number
    3012523063-2024-00037
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 13, 2024
    Report Date
    October 30, 2024
    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 THE INCIDENT DESCRIPTION, AN IMPACTOR WAS CRACKED DURING USE AND A PIECE BROKE OFF. THE IMPACTOR WAS PROVIDED FOR AN OPTICAL EXAMINATION. IT CAN BE SEEN THAT A SMALL PIECE BROKE OFF THE IMPACTOR. THERE IS ALSO A CRACK PRESENT THAT ORIGINATES FROM THE BROKEN OFF PIECE AN CONTINUES FOR AROUND THREE QUARTERS OF THE CIRCUMFERENCE OF THE IMPACTOR. IT IS KNOWN THAT THE FRACTURE OF THE IMPACTOR OCCURRED DURING USE/ INTRAOPERATIVELY. WHILE THE INLAY WAS IMPACTED, THE ISSUE OCCURRED, AFTER THE INLAY WAS ALREADY FIRMLY SEATED. THEREFORE, THERE WAS NO IMPACT ON THE PATIENT. FURTHERMORE, ANOTHER PRODUCT WOULD HAVE BEEN AVAILABLE. NONETHELESS, DUE TO THIS ISSUE, THERE WAS AN INCREASE OF THE SURGERY RELATED RISKS. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE IMPACTOR 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 IMPACTOR BROKE. IT CAN ONLY BE ASSUMED THAT THE INCIDENT CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE IMPACTOR. 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 "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING THE INCIDENT DESCRIPTION, AN IMPACTOR WAS CRACKED DURING USE AND A PIECE BROKE OFF. THE IMPACTOR WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION. SINCE THERE ARE ALSO NO PICTURES AVAILABLE, NO OPTICAL EXAMINATION COULD BE PERFORMED. IT IS KNOWN THAT THE FRACTURE OF THE IMPACTOR OCCURRED DURING USE/ INTRAOPERATIVELY. HOWEVER, THIS HAD NO HEALTH EFFECT ON THE PATIENT. HOW EXACTLY THE SURGERY WAS FINISHED IS NOT KNOWN. HOWEVER, IT IS VERY LIKELY THAT A SLIGHT EXTENSION OF THE SURGERY WAS CAUSED DUE TO THE REPORTED ERROR PATTERN. THE MANUFACTURING DOCUMENTS AND THE MATERIAL CERTIFICATES OF THE IMPACTOR 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 IMPACTOR BROKE. IT CAN ONLY BE ASSUMED THAT THE INCIDENT CAN BE REGARDED AS A RANDOM FAILURE OF A COMPONENT WITH REGARDS TO THE IMPACTOR. 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 "BREAK OF THE INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE HEAD IS CRACKED AND A PIECE HAS BROKEN OFF." REMARK IC-GMBH: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY, WHILE THE INLAY WAS IMPACTED. THE INLAY WAS ALREADY IN PLACE WHEN THE IMPACTOR CRACKED. THEREFORE, THERE WAS NO IMPACT ON THE PATIENT. FURTHERMORE, ANOTHER PRODUCT WAS AVAILABLE. NONETHELESS, DUE TO THIS ISSUE, THERE WAS AN INCREASE OF THE SURGERY RELATED RISKS.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "THE HEAD IS CRACKED AND A PIECE HAS BROKEN OFF." REMARK IC-GMBH: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY, HENCE IT IS VERY LIKELY THAT IT CAUSED AN EXTENSION OF THE SURGERY TIME. HOWEVER, ACCORDING TO THE AVAILABLE INFORMATION, THIS ISSUE HAD NO HEALTH IMPACT ON THE PATIENT. IT IS NOT KNOWN HOW EXACTLY THE SURGERY WAS FINISHED (E.G., IF A SECOND IMPACTOR WAS AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472756 IMPACTOR FOR CUP INSERT 32MM IMPACTOR HWA IMPLANTCAST GMBH 02820007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other