BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.6MM WIRE SLEEVE

    MDR report key: 3023459 · Received March 27, 2013

    Report

    Report Number
    2530088-2013-10308
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    August 22, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    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 SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. MANUFACTURING EVALUATION REVEALED THAT THE RETURNED DEVICE WAS MANUFACTURED IN JANUARY 2002. THE CUSTOMER ETCHED THEIR IDENTIFICATION ON THE SHAFT. THERE WAS SOME STAIN/DISCOLORATION WITH RUSTY APPEARANCE IN SOME AREAS. THE MICROSCOPIC INVESTIGATION CLEARLY SHOWS THAT THESE DISCOLORATIONS APPEARED BECAUSE OF INSUFFICIENT CLEANING AND MAINLY INSUFFICIENT DRYING PROCEDURES. REGARDING CORROSION IT CAN BE STATED, THAT ALL MATERIALS, INCLUDING SO CALLED STAINLESS STEEL AS WELL, ARE CONDITIONALLY ONLY RUST-RESISTANT. THE CORROSION RESISTANCE IS MAINTAINED ONLY, WHEN THE MATERIAL IS STORED ON A DRY AND METALLIC CONTACT LESS CONDITION. ALL METALLIC CONTACTS ON HUMID OR WET CONDITION CREATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS RESULT. BASED ON THE CONDITION OF THE RETURNED DEVICE AND THE EVALUATION, THE COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING STANDPOINT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE RUSTING INSTRUMENTS IN THE TRAYS. THE FACILITY HAS HAD THESE SPECIFIC TRAYS FOR ABOUT 7-8 YEARS. THE INSTRUMENTS ARE IN QUARANTINE AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT NOTED. THIS IS REPORT 3 OF 4 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126947 1.6MM WIRE SLEEVE FZX SYNTHES BRANDYWINE 4356972

    Patients

    Seq Age Sex Outcome Treatment
    1