BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY F/MINI-SCR W/LID

    MDR report key: 3163055 · Received June 11, 2013

    Report

    Report Number
    2520274-2013-02901
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    January 7, 2011
    Report Date
    January 13, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. (B)(6). ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE SCREWS SHOW SIGNS OF RUST JUST AT THE UNDERSIDE OF THE HEAD. THE ADDITIONAL EVALUATION REVEALED THAT THE PROVIDED SCREWS SHOW PATTERNS OF INADEQUATE DRIED OUT HUMIDITY DURING STORAGE. THE RESIDUAL MOISTURE AFTER CLEANING OR STERILIZATION PROCEDURES, ENABLED CORROSION OF AN INCREASED LEVEL, AND SEEMS TO BE THE SOURCE OF THE RUSTY SURFACE. NO PRODUCT FAULT COULD BE DETECTED.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE RUSTY SCREW HEADS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263569 TRAY F/MINI-SCR W/LID FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1