BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHISEL BOX CUTTING H5

    MDR report key: 3180689 · Received June 20, 2013

    Report

    Report Number
    8030965-2013-03404
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    June 6, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    EML
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE EVALUATION REVEALED THAT INSPECTION OF THE TWO CHISELS INCLUDED IN THIS COMPLAINT REVEALS THAT THE VISIBLE TRACES ON THE SURFACE ARE NOT ONLY COMPOSED OF RUST BUT ALSO INCLUDE ORGANIC RESIDUES. WE SUSPECT THAT THESE DEPOSITS ARE DUE TO RESIDUES LEFT BEHIND AFTER THE CLEANING AND STERILIZATION PROCESS. IN REGARD TO RUST FORMATION, IT CAN BE GENERALLY STATED THAT ALL MATERIALS, EVEN SO-CALLED RUST-FREE STEEL, IS ONLY RUSTPROOF TO A CERTAIN EXTENT. THE MATERIAL REMAINS RUSTPROOF ONLY AS LONG AS IT IS ALWAYS DRIED IMMEDIATELY AND STORED IN A DRY PLACE. NO PRODUCT DEFECT WAS DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHISELS ARE RUSTY. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279897 CHISEL BOX CUTTING H5 EML SYNTHES GMBH T920728

    Patients

    Seq Age Sex Outcome Treatment
    1