BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VET STD TPLO JIG

    MDR report key: 3183168 · Received June 21, 2013

    Report

    Report Number
    1719045-2013-01615
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. 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. THE ADDITIONAL EVALUATION REVEALED THAT THERE ARE SOME RUSTY SPOTS, BUT ALSO STICKY ORGANIC DEPOSITION WHICH IS MAINLY LOCATED IN THE DEEPENING AT THE HOLES. THIS CAN BE REMOVED BY BRUSHING WITH FOLLOWING ADEQUATE CLEANING PROCESS. PLEASE NOTE - REGARDING CORROSION IT CAN BE STATED TAT 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 CONTACTLESS CONDITION. ALL METALLIC CONTACTS ON HUMID OR WET CONDITION CREATE ELECTROLYTIC REACTIONS WITH CONTACT CORROSION AS A RESULT. AT THIS INSTRUMENT ONE RUSTY SPOT HAS THE FORM OF A SLOT WHICH IS A CLEAR INDICATION THAT ANOTHER WET INSTRUMENT WAS PLACED ON THIS JIG. HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 510K#: DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE.

    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 THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TPLA JIG HAS RUST SPOTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING STERILIZATION RUST SPOTS APPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283381 VET STD TPLO JIG FZX SYNTHES MONUMENT 6446647

    Patients

    Seq Age Sex Outcome Treatment
    1