BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMO PUNCH

    MDR report key: 7227046 · Received January 30, 2018

    Report

    Report Number
    9615005-2018-80005
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Date of Event
    January 19, 2018
    Report Date
    April 17, 2019
    Manufacturer
    FEHLING INSTRUMENTS GMBH & CO. KG
    Product Code
    LRY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS WE HAVEN'T RECEIVED THE INSTRUMENT OR THE BATCH NUMBER, WE CANNOT MAKE ANY FURTHER INVESTIGATIONS. THEREFORE, WE ARE CLOSING THE FILE. SHOULD WE RECEIVE ANY NEW INFORMATION, WE WILL REPORT AGAIN TO THE FDA.

    Description of Event or Problem · 0

    DURING SURGERY THE FOOTPLATE OF THE PUNCH (ARTICLE NUMBER NZY-8F) BROKE APART. AS OF OUR KNOWLEDGE OF TODAY, THE FRAGMENT WAS REMOVED COMPLETELY. NO PART WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    DURING SURGERY THE FOOTPLATE OF THE PUNCH (ARTICLE NUMBER (B)(4)) BROKE APART. AS OF OUR KNOWLEDGE OF TODAY THE FRAGMENT WAS REMOVED COMPLETELY. NO PART WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73000 CERAMO PUNCH EJECTOR PUNCH LRY FEHLING INSTRUMENTS GMBH & CO. KG NZY-8F

    Patients

    Seq Age Sex Outcome Treatment
    1