BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE W/O INSTRUMENT TRAY FOR TI MOD HAND SYSTEM

    MDR report key: 3081846 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11159
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 16, 2011
    Report Date
    November 16, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. THE VISUAL INSPECTION PERFORMED AS PART OF THE PRODUCT EVALUATION REVEALED THE NYLON COATING IS BRITTLE, DISCOLORED AND PEELING OFF THE BRACKETS INSIDE THE CASE THAT HOLD THE MODULES. THERE ARE NUMEROUS SURFACE SCRATCHES ALL OVER THE CASE AND LID. THE LID SLIDES ON AND OFF EASILY AND THE LATCHES WORK ACCEPTABLY. THERE IS LETTERING ON THE UNDERSIDE OF THE LID THAT HAS BEEN TRANSFERRED FROM DOCUMENTS THAT HAVE COME INTO CONTACT WITH THE LID. THERE IS ALSO THE WORDS, PUT SHEET IN TRAY, HAND WRITTEN IN MARKER ON THE TOP OF THE LID AND OPS ON THE FRONT OF THE CASE. THE DOOR OPENS AND CLOSES EASILY BUT THE LATCH IS SLIGHTLY BENT AND PROVIDES VERY LITTLE ENGAGEMENT. NO LOT NUMBER IS AVAILABLE, SO THE AGE OF THE CASE CANNOT BE DETERMINED, BUT BASED ON THE CONDITION OF THE RETURNED PART, THIS CASE IS VERY OLD AND HAS BEEN USED EXTENSIVELY. THERE ARE NO INDICATIONS OF ANY MANUFACTURING OR DESIGN RELATED ISSUES AND THE NYLON COATING BEING OLD, BRITTLE AND PEELING OFF THE BRACKETS IS DUE TO THE AGE AND EXPOSURE TO SO MANY STERILIZATION CYCLES OVER THAT SERVICE TIME. NO DESIGN OR MANUFACTURING ISSUES EVIDENT, CONDITION DUE TO AGE OF DEVICE THE INVESTIGATION HAS CONCLUDED THIS COMPLAINT IS INVALID.

    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. ORIGINAL AWARENESS DATE IS (B)(4) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    ACCOUNT REPORTED TO THE CONSULTANT THE GRAPHIC CASE FOR TI MOD HAND SYSTEM CASE WAS PEELING ON THE INSIDE OF THE CASE. IT CANNOT BE USED FOR SURGERY THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183426 GRAPHIC CASE W/O INSTRUMENT TRAY FOR TI MOD HAND SYSTEM FSM SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1