BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE/FULL LENGTH 4 BAY/F/MODULAR GC SYSTEM

    MDR report key: 3072446 · Received April 23, 2013

    Report

    Report Number
    3003787298-2013-10091
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    July 3, 2012
    Report Date
    July 3, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 PRODUCT DEVELOPMENT EVALUATION REVEALED THAT THE 60.116.001 CASE WAS RECEIVED WITH DELAMINATION OF THE NYLON COATING; IT WAS NOT WEARING OFF AS THE COMPLAINT STATED. THE 60.116.001 GRAPHIC CASE WAS DESIGNED IN 2009 AND MEETS THE DESIGN CRITERIA SET FORTH IN GRAPHIC CASE WORK INSTRUCTION ES0321, AND FUNCTIONAL AND DESIGN VERIFICATION AND VALIDATION MATRIX. GRAPHIC CASES HAVE INCORPORATED NYLON COATING FOR MORE THAN FIFTEEN YEARS AND THE COATING HAS PROVEN TO BE DURABLE. THE MANUFACTURING EVALUATION SHOWED THAT THE UNIT PN (60.116.001) WAS RETURNED. THE AS RECEIVED CONDITION IS NOTED AS HEAVILY WORN WITH MULTIPLE INDICATIONS THAT THE UNIT WAS HEAVILY USED IN THE FIELD. THE CASE BASE ASSEMBLY PN (60.116.001.10) HAS BLUE RESIDUE FROM THE STERILIZATION PAPER USED TO WRAP THESE UNITS DURING THE STERILIZATION PROCESS PERMANENTLY ETCHED OR ADHERED TO THE NYLON COATING. THE HEAVY AMOUNT OF COLOR THAT HAS BLED ONTO THE CASE SURFACES INDICATE THAT THE CASE WAS IN THE FIELD FOR A SIGNIFICANT PERIOD OF TIME. THERE ARE MULTIPLE LOCATIONS ON VARIOUS CORNERS AND EDGES OF BOTH THE BASE ASSEMBLY AND LID PN (60.116.015) THAT INDICATE DAMAGE FROM ROUGH HANDLING AND HARD CONTACT WITH OTHER UNKNOWN SURFACES. NO LOT NUMBER WAS SUBMITTED FOR THIS COMPLAINT. A REVIEW OF THE DCO HISTORY INDICATES THAT THE UNIT WAS MANUFACTURED TO REVISION A. TOP LEVEL DRAWINGS FOR PN (60.116.001) REV D WILL BE USED FOR THIS INVESTIGATION. IT IS CONCLUDED THAT THE UNIT WAS MANUFACTURED PRIOR TO 6/10/10 AND HAS BEEN HEAVILY USED AS INDICATED IN THE AS RECEIVED CONDITION. THERE ARE MULTIPLE AREAS OF DAMAGE TO THE NYLON COATING THAT HAVE COMPROMISED THE NYLON AT THOSE LOCATIONS CAUSING BASE MATERIAL TO BE EXPOSED. THE SEVERITY OF DAMAGE AT THE COMPLAINED LOCATION IS INDICATIVE OF CONTACT WITH ANOTHER SURFACE WITH SUFFICIENT FORCE TO CRACK THE NYLON COATING CAUSING THE NYLON TO PEEL. THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING PERSPECTIVE. 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. ORIGINAL AWARENESS DATE IS 7/3/12.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DISTAL RADIUS PROCEDURE, SCHEDULED FOR 8 AM, IT WAS NOTICED THAT THE NYLON COATING ON THIS GRAPHIC CASE IS WEARING OFF, LEAVING SHARP EDGES THAT CUT THROUGH THE STERILE WRAPPING PRIOR TO SURGERY. THE SURGERY WAS RESCHEDULED FOR LATER IN THE DAY, 2PM, WHILE THE GRAPHIC CASE WAS RE-STERILIZED. THE CASE PROCEEDED WITHOUT FURTHER INCIDENT AND NO ADVERSE EFFECT TO PATIENT WAS NOTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174285 GRAPHIC CASE/FULL LENGTH 4 BAY/F/MODULAR GC SYSTEM FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1