BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMO RONGEUR WITH EJECTOR

    MDR report key: 5811525 · Received July 21, 2016

    Report

    Report Number
    9615005-2016-80002
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 3, 2016
    Manufacturer
    FEHLING INSTRUMENTS GMBH
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS MDR IS RELATED TO (B)(4). IT WAS REPORTED THAT A CERAMO RONGEUR BREAK DURING SURGERY. ACCORDING TO THE LOT NR. AND TO THE PICTURES: THE CERAMO RONGEUR WITH EJECTOR NNN-2S (40° AUFW., 3,0 X 200 MM) HAS BEEN IN USE FOR A BIT LESS THAN 4 YEARS. THE DIFFERENT SCREWS OF THE SEEM VERY USED. THE SMALLER SCREW ON THE SHAFT OF THE BONE PUNCH SEEMS TO HAVE BEEN "REBUILT". WE ASSET THAT THE BIGGER SCREW HAD BEEN REBUILT TOO, IN ORDER TO MAKE OUT OF AN NON-DETACHABLE RONGEUR A DETACHABLE ONE. THE THREAD OF THE SCREW MIGHT HAVE BEEN DAMAGED FROM THE DIS- AND REASSEMBLY OVER THE YEARS. THIS SPECIAL RONGEURS ARE NOT DETACHABLE, THEY ARE TO BE CLEANED AND STERILIZED WITHOUT PRIOR DISASSEMBLY. MEASURES: WHEN THE DAMAGE INSTRUMENT ARRIVED FURTHER INVESTIGATION WILL BE CONDUCTED TO CONFIRM OR NOT THE PREVIOUS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467774 CERAMO RONGEUR WITH EJECTOR CERAMO RONGEUR HAE FEHLING INSTRUMENTS GMBH NNN-2S X11M556

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization