BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE F/MATMAND F/6-40

    MDR report key: 3151244 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02772
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    April 1, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE SLIDER PRESENTS SOME SPURS OF CORROSION. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. IN GENERAL WE HAVE TO POINT OUT THAT EVEN SO CALLED STAINLESS STEEL IS ONLY RUST RESISTANT. THE CORROSION RESISTANCE IS ONLY ENSURED WHEN THE PRODUCTS ARE STORED AT DRY CONDITIONS. IN ADDITION ALL METALLIC CONTACTS ARE HUMID OR WET CONDITIONS MAY CREATE ELECTROLYTIC REACTIONS RESULTING IN CONTACT CORROSION. ACCORDING TO THE DEVICE REPORT THE PRESENT DEPTH GAUGE WAS IN CONTACT WITH SOME RUSTY HOLDING FORCEPS. WE THEREFORE, CLASSIFY THIS OCCURRENCE AS CONTACT CORROSION. CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. AS THE DEVICE WAS IN CONTACT WITH SOME RUSTY HOLDING FORCEPS, WE CLASSIFY THIS OCCURRENCE AS CONTACT CORROSION AND THE DEVICE FAILURE IS RELATED TO THE CLEANING AND MAINTENANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SHOWS SIGNS OF CORROSION. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250777 DEPTH GAUGE F/MATMAND F/6-40 HTJ SYNTHES GMBH 2487146

    Patients

    Seq Age Sex Outcome Treatment
    1