BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE COATED 6" BLADE ELECTRODE, GEO-MED

    MDR report key: 4752158 · Received May 5, 2015

    Report

    Report Number
    1060680-2015-00030
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    June 6, 2013
    Report Date
    May 1, 2015
    Manufacturer
    MODERN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K962935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE IDENTIFIED REPORTS HAVE BEEN RE-OPENED IN REFERENCE TO THE VENDOR'S IDENTIFIED CORRECTIVE ACTIONS. DUE TO THE REPORTING CUSTOMER FILLING THREE REPORTS FOR THE ISSUE OF THE "TIPS BREAKING", THE FOLLOWING SCARS WERE ENTERED IN TO THE SYSTEM: (B)(4); (B)(4); AND (B)(4). THE VENDOR HAS RESPONDED TO UPDATE THE SCAR RESPONSE AND HAS TITLED THE UPDATE AS ADDITIONAL INFO TO (B)(4). WITHIN THIS RESPONSE IT WAS STATED, "WE WOULD LIKE TO CHECK WITH DEROYAL TEAM AGAIN AND SEE IF THERE IS ANY AVAILABLE INFO. IF NOT, THERE IS NO FURTHER ACTION WE CAN DO TO EVALUATE THE IMPROPER USE OF PRODUCT." DEROYAL HAS RESPONDED TO THE VENDOR ON (B)(6) 2014, THAT ADDITIONAL INFO IS NOT AVAILABLE. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: UPDATED: UNDETERMINED: THE VENDOR HAS NOT RECEIVED INFO AS TO THE QUANTITY OF TIMES THE PRODUCT WAS BENT DURING THE USE IN THE FIELD. THE ELECTRODE IS NOT DESIGNED FO BENDING OR FURTHER MODIFICATION AFTER OPENING OUR STERILE PACKAGE. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTIVE ACTION TAKEN: UPDATED: WITHIN THE IFU COPY "(B)(4)". WE HAVE DECLARED A STATEMENT OF WARNING SECTION #10- "MODERN MEDICAL EQUIPMENT MANUFACTURING LTD EXPLICITLY WARNS AGAINST MAKING ANY CHANGES TO THE DEVICE. ANY SUCH CHANGE WILL EXEMPT US FROM ALL LIABILITIES." REV. 2 ISSUED ON 6/14/2013.) PREVIOUS: CONSIDER TO DESIGN ANOTHER BENDABLE ELECTRODE FOR CUSTOMER ((B)(6), COMPLETION DATE (B)(6) 2013) UPDATED: THE VENDOR WOULD LIKE TO REMOVE THE ITEM FROM THIS SCAR BECAUSE THERE IS NO INTENTION FROM DEROYAL OR MMEQ TO DEVELOP A BRAND NEW SERIES OF PRODUCTS FOR BENDABLE FUNCTION. ALSO, WE DO NOT HAVE A NEW SERIES OF ELECTRODE FOR BENDABLE USE AND WE DO NOT THINK THIS WILL HELP RESOLVE THE ISSUE AT THE MOMENT. IT IS ONLY A RECOMMENDATION, NO FURTHER ACTION IS NECESSARY. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THIS REPORT IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS. THIS COMPLAINT HAS BEEN RE-OPENED FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INVESTIGATION PROVIDES INFO WHICH CHANGES THE CONTENT OF THIS REPORT.

    Description of Event or Problem · 1

    HIP SURGERY TIPS BROKE OFF DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292752 PTFE COATED 6" BLADE ELECTRODE, GEO-MED GEI MODERN MEDICAL 31174572

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention