BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIP SZ. 30 PROXIMAL

    MDR report key: 10277446 · Received July 15, 2020

    Report

    Report Number
    1651501-2020-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    December 26, 2019
    Report Date
    December 26, 2019
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    OMX
    PMA / PMN Number
    H010005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RECEIVED FOR EVALUATION. DHR - A REVIEW OF THE LOT RECORDS WAS CONDUCTED AND THERE WERE NO INDICATIONS OF PROBLEMS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. THE PART WAS NOT RETURNED TO INTEGRA FOR INVESTIGATION, SO THE FAILURE COULD NOT BE CONFIRMED AS THE PART WAS NOT RETURNED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. HOWEVER, IN REVIEW OF OTHER SIMILAR COMPLAINTS, SIMILAR ISSUES THAT RESULTED IN INTRAOPERATIVE PIP FRACTURES HAVE BEEN ATTRIBUTED TO IMPROPERLY PREPARED OBLIQUE OSTEOTOMY, IMPROPER PLACEMENT OF THE IMPLANT (E.G., IMPACTING UNSUPPORTED HEAD WITH TOO MUCH FORCE), OR IMPROPER IMPLANT SIZE SELECTION. IF THE PART IS LATER RETURNED, THIS COMPLAINT MAY BE REOPENED AND FURTHER INVESTIGATION CONDUCTED. 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)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. BETWEEN (B)(6) 2019 AND (B)(6) 2020, 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 (B)(6). 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 (B)(4) 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 (B)(6) 2019 THROUGH (B)(6) 2020. INTEGRA LIFESCIENCES CONTACTED (B)(6), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6), ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON (B)(6) 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT DURING A PIP ARTHROPLASTY ON (B)(6) 2019, THE PROXIMAL IMPLANT BROKE IN HALF DURING IMPACTION. THERE WAS NO REPORTED PATIENT INJURY AND NO DELAY IN SURGERY DUE TO PRODUCT PROBLEM. AN X-RAY WAS TAKEN AND NO BROKEN PARTS RECOVERED SINCE NO PART OF THE DEVICE FELL INTO THE SURGICAL SITE. MOREOVER, WHEN THE DEVICE BROKE THEY DRILLED IT OUT AND WENT UP A SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739036 PIP SZ. 30 PROXIMAL PIP OMX ASCENSION ORTHOPEDICS 193350T

    Patients

    Seq Age Sex Outcome Treatment
    1