BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT TRAY F/2.7MM CRTX/ LOCKING/VAL SCREWS F/GC SYS

    MDR report key: 3054721 · Received April 12, 2013

    Report

    Report Number
    3003787298-2013-10066
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Report Date
    April 24, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE RECEIVED CONDITION IS NOTED AS USED WITH SIGNS OF WEAR OR DAMAGE IN THE FIELD. THE COMPLAINED UNIT HAS NYLON COATING LOCATED ON THE INNER CORNERS ON THE TOP SURFACE OF THE TRAY THAT HAS DELAMINATED BUT ARE INTACT AND HAVE NOT BROKEN OR BEEN COMPROMISED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. THE DEVICE WAS RECEIVED, HOWEVER, NO EVALUATION IS AVAILABLE.

    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. ADDITIONAL INFORMATION: A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED WHICH INCLUDED A MANUFACTURING EVALUATION. THE GRAPHIC CASE WAS RECEIVED AND THE NYLON COATING ON THE TOP SURFACE OF THE TRAY HAS DELAMINATED AS NOTED IN THE AS RECEIVED CONDITION. THE AS RECEIVED CONDITION IS NOTED AS BEING USED WITH SIGNS OF WEAR OR DAMAGE IN THE FIELD. THE OUTER WALLS AND CORNERS OF THE BASE ASSEMBLY DISPLAY DEEP GOUGES AND SCRATCHES. ALSO NOTED ARE REMNANTS OF TEXT FROM THE STERILIZATION WRAP AND BLACK MARKER. THERE ARE NO INDICATIONS OF NYLON BUBBLING OR DELAMINATION ON THE INTERIOR OR EXTERIOR OF THE BASE ASSEMBLY. THE LID IS NOTED TO HAVE THE SAME DAMAGE AS INDICATED ON THE BASE ASSEMBLY. THE NYLON SURFACE ON THE UNDERSIDE OF THE LID HAS DELAMINATED ALONG THE ENTIRE LENGTH OF THE 90 DEGREE FOLD AND EXTENDS OUT FROM THE INNER CORNER APPROXIMATELY 35MM TOWARDS THE CENTER OF THE LID. THE DELAMINATION SITE IS INTACT AND HAS NOT BEEN BROKEN OR BEEN COMPROMISED. ALSO, INCLUDED WITH THE COMPLAINED UNIT WERE THE TWO TRAY ASSEMBLIES P/N (60.116.022) AND P/N (60.112.040). THE NYLON COATING LOCATED ON THE INNER CORNERS ON THE TOP SURFACE OF BOTH TRAYS HAVE DELAMINATED BUT ARE INTACT AND HAVE NOT BROKEN OR BEEN COMPROMISED. NO LOT NUMBER WAS SUBMITTED FOR THIS COMPLAINT FOR ANY OF THE DEVICES AND WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. HOWEVER, THE PRINT SPECIFICATIONS WERE REVIEWED AND A REVIEW OF THE MANUFACTURING TECHNIQUES USED ON THE SUBJECT BASE ASSEMBLY HAS DETERMINED THAT THE BASE ASSEMBLY UNIT WAS NOT MANUFACTURED OR ASSEMBLED AT (B)(4). THE NYLON SPRAY OPERATION FOR THE LID IS CURRENTLY PERFORMED BY OUTSIDE VENDORS. THE REVIEW DETERMINED THAT ALL SPRAY NYLON SERVICES TO DATE HAVE BEEN PROVIDED BY PCT INC. THE UNDERSIDE NYLON SURFACE OF THE LID HAS DELAMINATED ALONG THE INNER EDGE AREAS AS COMPLAINED WITH NO OBVIOUS SIGNS OF CAUSE. THIS COMPLAINT IS DEEMED VALID FROM A MANUFACTURING PERSPECTIVE. A SUPPLIER PRODUCT INVESTIGATION, SPECIFICALLY A NYLON DELAMINATION INVESTIGATION HAS BEEN COMPLETED BY PCT FOR A PREVIOUS COMPLAINT ID ((B)(4)). THE INVESTIGATION RESULTS AND ROOT CAUSE ANALYSIS FOR THIS PREVIOUS COMPLAINT ((B)(4)) HAVE DETERMINED THE ROOT CAUSE AS INSUFFICIENT PRIMER APPLIED TO CORNERS OF THE PART. WHILE THE PART DOES SHOW EVIDENCE OF BEING PRIMED PER SPECIFICATION, THE PRIMER WAS NOT APPLIED IN SUFFICIENT AMOUNT TO PROVIDE SUFFICIENT ADHESION OF COATING. PRIMER IS A MANUAL SPRAY OPERATION AND THE OPERATOR DID NOT DIRECT SPRAY INTO THE CORNERS SUFFICIENTLY. THE SUPPLIERS SPRAY PRIMING WORK INSTRUCTION WERE IMPROVED IN JANUARY 2012, INSTRUCTING OPERATORS TO SPRAY PAINT TO DETAIL AND TO DIRECT SPRAY DIRECTLY INTO THE CORNERS BEFORE SPRAYING THE FLAT SURFACES. WITHOUT A LOT NUMBER FOR THE CURRENT COMPLAINT IT IS UNKNOWN IF THE DEVICES INVOLVED WERE MANUFACTURED BEFORE OR AFTER THE SUPPLIERS SPRAY PRIMING WORK INSTRUCTION WERE IMPROVED. A DESIGN EVALUATION WAS CONDUCTED AND THIS GRAPHIC CASE WAS DESIGNED IN 2009 AND MEETS THE DESIGN CRITERIA SET FORTH IN THE GRAPHIC CASE WORK INSTRUCTIONS AND FUNCTIONAL AND DESIGN VERIFICATION AND VALIDATION MATRIX. CONCLUSION: THE OVERALL ANALYSIS HAS INDICATED THAT NO ROOT CAUSE CAN BE FOUND FOR THE REPORTED COMPLAINT. WITHOUT A LOT NUMBER FOR THE CURRENT COMPLAINT IT IS UNKNOWN IF THE DEVICES INVOLVED WERE MANUFACTURED BEFORE OR AFTER THE SUPPLIERS SPRAY PRIMING WORK INSTRUCTION WERE IMPROVED. THE GRAPHIC CASES HAVE INCORPORATED NYLON COATING OVER ALUMINUM SUBSTRATE FOR MORE THAN FIFTEEN YEARS AND HAVE PROVEN TO BE FOUND DURABLE. FROM A DESIGN STANDPOINT, IT IS DETERMINED THAT THIS COMPLAINT IS INVALID. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4). CORRECT MANUFACTURER INFORMATION IS SYNTHES (B)(4).

    Description of Event or Problem · 1

    CONSULTANT REPORTS THAT THE NYLON COATING OF THE GRAPHIC CASE AND TRAY IS BLISTERING. THERE WAS NO PATIENT INVOLVEMENT. THIS IS A FAIRLY NEW GRAPHIC CASE. THIS IS 3 OF 3 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158471 INSTRUMENT TRAY F/2.7MM CRTX/ LOCKING/VAL SCREWS F/GC SYS LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1