BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8510038 · Received April 12, 2019

    Report

    Report Number
    1221934-2019-56834
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Report Date
    March 20, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    UDI-DI
    10886705023479
    PMA / PMN Number
    K130917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE, UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. NO NONCONFORMANCES WERE IDENTIFIED FOR THIS PART (222331) - LOT NUMBER (L789973) COMBINATION AS PER QLIK QUERY EXECUTED 04/09/2019. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. IF ANY ADDITIONAL INFORMATION IS OBTAINED, THIS COMPLAINT WILL BE RE-OPENED TO CAPTURE THAT INFORMATION. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING AN ARCR PROCEDURE THE ANCHORS WERE BROKEN. THE PROCEDURE WAS FINISHED WITHOUT ANY OTHER PROBLEM, ALTHOUGH IT WAS NOT STATED HOW IT WAS FINISHED. THERE WAS NO BROKEN PARTS INSIDE OF THE PATIENT'S BODY. THE DEVICE WAS BRAND NEW AND FIRST TIME USE WHEN THE ISSUE OCCURRED. THE AFFILIATE REPORTED THAT THERE WAS LESS THAN A 30 MINUTE TIME DELAY AND NO HARM TO THE PATIENT. THE AFFILIATE ALSO REPORTED THAT THERE WAS NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301221 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US L789973 10886705023479

    Patients

    Seq Age Sex Outcome Treatment
    1