BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE KNTLSS BR

    MDR report key: 8277850 · Received January 25, 2019

    Report

    Report Number
    1221934-2019-56120
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    May 18, 2017
    Report Date
    May 18, 2017
    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

    IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. (B)(4). THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. A NON-CONFORMANCE SEARCH WAS PERFORMED FOR THIS PRODUCT CODE 222331-LOT #3927418 COMBINATION AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 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. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX ADVANCE KNTLSS BR DEVICE BROKE. ACCORDING TO THE REPORTER, THE EVENT OCCURRED WHEN THE THREAD WAS PASSED THROUGH THE ANCHOR. IT WAS REPORTED THAT THE DEVICE WAS BRAND NEW AND ON ITS FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70811 5.5 HEALIX ADVANCE KNTLSS BR SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US 3927418 10886705023479

    Patients

    Seq Age Sex Outcome Treatment
    1