BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LID 2/3 LENGTH F/MODULAR GRAPHIC CASE SYSTEM

    MDR report key: 3070971 · Received April 22, 2013

    Report

    Report Number
    3003787298-2013-10087
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    August 16, 2012
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH 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 MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ONE UNIT P/N (60.116.016) WAS RECEIVED ON COMPLAINT ID (14886). THE RECEIVED CONDITION IS NOTED AS USED WITH NO OBVIOUS SIGNS OF WEAR OR DAMAGE IN THE FIELD. THE AREA LOCATED ALONG 1 OF 2 INNER FOLD LINES (353.2MM LENGTH) OF THE TRAY SURFACE APPEARS TO HAVE BUBBLED OR DELAMINATED FROM THE SUBSTRATE MATERIAL. THE NYLON SURFACE AT DELAMINATION SITE IS INTACT AND HAS NOT BEEN BROKEN OR COMPROMISED. A REVIEW OF THE MANUFACTURING TECHNIQUES USED ON THE SUBJECT LID HAS DETERMINED THAT THE UNIT WAS MANUFACTURED AT (B)(4). THE NYLON SPRAY OPERATION IS CURRENTLY PERFORMED BY OUTSIDE VENDORS. A JDE REVIEW HAS DETERMINED THAT ALL SPRAY NYLON SERVICES TO DATE FOR P/N (60.116.016) HAVE BEEN PROVIDED BY PCT INC. THE NYLON SURFACE HAS DELAMINATED ALONG THE INNER EDGE AREAS AS COMPLAINED WITH NO OBVIOUS SIGNS OF CAUSE. THIS COMPLAINT IS DEEMED VALID FROM A MANUFACTURING PERSPECTIVE. SUPPLIER PRODUCT INVESTIGATION RESULTS HAVE DETERMINED THE ROOT CAUSE AS INSUFFICIENT PRIMER APPLIED TO CORNERS OF PART. PART CALLS FOR PRIMER. PART DOES SHOW EVIDENCE OF BEING PRIMED PER SPECIFICATION. HOWEVER, PRIMER WAS NOT APPLIED IN SUFFICIENT AMOUNT TO PROVIDE SUFFICIENT ADHESION OF COATING. PRIMER IS A MANUAL SPRAY OPERATION AND OPERATOR DID NOT DIRECT SPRAY PATTERN INTO THE CORNERS SUFFICIENTLY. CORRECTIVE ACTION: IMPROVE WORK INSTRUCTION AT SPRAY PRIMING TO DETAIL DIRECT SPRAY DIRECTLY INTO CORNERS BEFORE SPRAYING FLAT SURFACES.

    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 8/16/12.

    Description of Event or Problem · 1

    SYNTHES (B)(4) TRAUMA PRODUCT MANAGER, REPORTED (SYNTHES (B)(4) SALES CONSULTANT) ADVISED AFTER A CASE AT (B)(6) HOSPITAL THAT HE NOTICED SOME BUBBLING OF THE RUBBERIZED COATING AND DELAMINATING ON THE INSIDE OF THE GRAPHIC CASE LID (60.116.016). THERE IS A 2ND LID STARTING TO HAVE THE SAME ISSUE. (2 LIDS ARE CURRENTLY BUBBLING). EVENT #1 OF 2 FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171010 LID 2/3 LENGTH F/MODULAR GRAPHIC CASE SYSTEM FSM SYNTHES JENNERSVILLE 6498085

    Patients

    Seq Age Sex Outcome Treatment
    1