BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP (5 PACK)

    MDR report key: 10276952 · Received July 15, 2020

    Report

    Report Number
    3006697299-2019-00160
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    November 29, 2019
    Report Date
    December 2, 2019
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K161882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6, H10. THE DEVICE WAS RETURNED FOR EVALUATION. THE INCIDENT WAS ISSUED TO CATALOG C7411S, CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (5 PACK); HOWEVER, THE DHR REVIEW CANNOT BE COMPLETED SINCE THE CUSTOMER DID NOT PROVIDED FG LOT NUMBER. INSPECTION OF PRODUCT SHOWED THAT NO CRACKS, FRACTURES, OR DEFORMATIONS WERE PRESENT ON C7411S CUSA CLARITY CURVED EXTENDED MICRO TIP. THE REPORTED COMPLAINT IS NOT CONFIRMED. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(4) OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED IN BEHALF OF THE CUSTOMER THAT A C7411S CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP¿ (5 PACK), COULD NOT FRACTURE THE TUMOR WITH THE INITIAL SETTING ON (B)(6) 2019. INITIAL SETTING WAS AMPLITUDE: 60, ASPIRATION: 60, IRRIGATION: 3, TISSUESELECT :0. THE AMPLITUDE WAS CHANGED TO 80, HOWEVER THE ISSUE CONTINUED AND THE HANDLE OF THE HANDPIECE HEATED GRADUALLY. THEY STOPPED USING THE PRODUCT AND ANOTHER DEVICE (SONOPET) WAS USED. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739549 CUSA CLARITY 36KHZ CURVED EXTENDED MICROTIP (5 PACK) CUSA CLARITY LFL INTEGRA LIFESCIENCES(IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1