BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTINIA® BROACH 11

    MDR report key: 20469675 · Received October 17, 2024

    Report

    Report Number
    3012523063-2024-00046
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Report Date
    November 14, 2024
    Manufacturer
    IMPLANTCAST GMBH
    Product Code
    LZO
    PMA / PMN Number
    K232371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INCIDENT DESCRIPTION, AN ACTINIA® BROACH WAS FOUND TO BE DULL/ BLUNT DURING USE. THE AFFECTED BROACH WAS NOT PROVIDED FOR AN OPTICAL EXAMINATION. SINCE NO PICTURES ARE AVAILABLE NEITHER, NO OPTICAL EXAMINATION COULD BE CARRIED OUT. IT IS KNOWN THAT THE ISSUE WAS DETECTED DURING USE/ INTRAOPERATIVELY. THE ISSUE HAD NO HEALTH EFFECT ON THE PATIENT, AS IT WAS POSSIBLE TO FINISH THE SURGERY WITH THE BROACH IN QUESTION. 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 BROACH 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, IT IS ASSUMED THAT THE ISSUE OCCURRED DUE TO WEAR AND TEAR. THE BROACH WAS MANUFACTURED IN 2018 AND IS THEREFORE IN USE FOR APPROXIMATELY 6 YEARS. IF IT WAS USED ON A FREQUENT BASIS, IT IS SAFE TO SAY THAT THE BROACH BECAME DULL OVER TIME. ANOTHER FACTOR THAT MAY HAVE CONTRIBUTED TO THE ISSUE IS THE CONDITION OF THE BONE. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BLUNT INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INCIDENT DESCRIPTION, AN ACTINIA® BROACH WAS FOUND TO BE DULL/ BLUNT DURING USE. THE AFFECTED BROACH WAS PROVIDED FOR AN OPTICAL EXAMINATION. THE BROACH HAS SEVERAL EDGES TO CREATE A CAVITY INSIDE THE BONE. SOME OF THESE EDGES PRESENT SOME MINOR DAMAGES. IT IS KNOWN THAT THE ISSUE WAS DETECTED DURING USE/ INTRAOPERATIVELY. THE ISSUE HAD NO HEALTH EFFECT ON THE PATIENT, AS IT WAS POSSIBLE TO FINISH THE SURGERY WITH THE BROACH IN QUESTION. 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 BROACH 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, IT IS ASSUMED THAT THE ISSUE OCCURRED DUE TO WEAR AND TEAR. THE BROACH WAS MANUFACTURED IN 2018 AND IS THEREFORE IN USE FOR APPROXIMATELY 6 YEARS. IF IT WAS USED ON A FREQUENT BASIS, IT IS SAFE TO SAY THAT THE BROACH BECAME DULL OVER TIME. ANOTHER FACTOR THAT MAY HAVE CONTRIBUTED TO THE ISSUE IS THE CONDITION OF THE BONE. THIS EVENT WAS ASSIGNED TO THE ERROR PATTERN "BLUNT INSTRUMENT" IN THE ASSOCIATED RISK MANAGEMENT.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DULL/ BLUNT". REMARK IC-GMBH: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. THE SURGERY WAS FINISHED WITH THE BROACH IN QUESTION. IT IS KNOWN THAT THERE WAS NO HEALTH EFFECT ON THE PATIENT, HOWEVER IT IS VERY LIKELY THAT THE ISSUE CAUSED AT LEAST A SLIGHT EXTENSION OF THE SURGERY TIME.

    Description of Event or Problem · 0

    THE FOLLOWING EVENT WAS REPORTED TO IMPLANTCAST GMBH: "DULL/ BLUNT" REMARK IC-GMBH: IT IS KNOWN THAT THE ISSUE OCCURRED INTRAOPERATIVELY. THE SURGERY WAS FINISHED WITH THE BROACH IN QUESTION. IT IS KNOWN THAT THERE WAS NO HEALTH EFFECT ON THE PATIENT, HOWEVER IT IS VERY LIKELY THAT THE ISSUE CAUSED AT LEAST A SLIGHT EXTENSION OF THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287061 ACTINIA® BROACH 11 BROACH LZO IMPLANTCAST GMBH 80049011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other