BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE HOLDER CEV738T5 DIA 5MM TUNGSTEN

    MDR report key: 9317482 · Received November 13, 2019

    Report

    Report Number
    2523190-2019-00141
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 21, 2019
    Report Date
    October 24, 2019
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    HET
    PMA / PMN Number
    K080257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS RETURNED, AND THE EVALUATION VERIFIED THE COMPLAINT AS VALID. DHR FOR LOT NO. 090801 REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WAS OBSERVED. THE MOBILE JAW IS BROKEN. THE FRAGMENT WAS RETURNED. A CORRODED AREA WAS OBSERVED WITHIN THE FRACTURE ZONE, SUGGESTING THE PRESENCE OF A CRACK PRIOR TO THE BREAKAGE. THE DEVICE WAS MANUFACTURED BEFORE THE ADDITION OF THE EFFORT COMPENSATION SYSTEM. CONSIDERING THE DATE OF MANUFACTURE, THERE WAS NO MATERIAL OR MANUFACTURING DEFECT FOUND. THE MOST PROBABLE CAUSE OF THIS RUPTURE IS THE RECURRENCE OF IMPACTS ON THE INSTRUMENT DURING ITS USE OR ITS REPROCESSING, WHICH WEAKENED THE JAW AND PROGRESSIVELY LED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE PROVIDED WITH THE DEVICE REQUIRES TO: "CHECK THE CONDITION OF INSTRUMENTS BEFORE AND AFTER EACH CASE. REMOVE FROM USE ANY INCOMPLETE OR POORLY OPERATION INSTRUMENTS". 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), DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(4), 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

    THE DEVICE WAS NOT 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

    IT WAS REPORTED THAT ON (B)(6) 2019, DURING A LAPAROSCOPIC CLOSURE OF THE VAGINAL FUNDUS ON A (B)(6)-YEAR-OLD FEMALE, THE CEV738T5 NEEDLE HOLDER DIA 5MM TUNGSTEN, A NEEDLE 25 AND VICRYL 0, WAS USED FOR SUTURING. AFTER THE COMPLETION OF TWO SUTURES, AND DURING THE START OF THE THIRD SUTURE, ONE OF THE JAWS BROKE IN THE ABDOMEN OF THE PATIENT. THE BROKEN PART WAS MANAGED TO BE RETRIEVED BY LAPAROSCOPY. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR A SURGICAL DELAY. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108318 NEEDLE HOLDER CEV738T5 DIA 5MM TUNGSTEN PFM16 HET INTEGRA MICROFRANCE S.A.S. 090801

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR