BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK 4.5MM HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD

    MDR report key: 4903049 · Received July 9, 2015

    Report

    Report Number
    1221934-2015-00857
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K120078
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED; IT WAS DISCARDED BY THE CUSTOMER AND THEREFORE IS UNAVAILABLE FOR A PHYSICAL EVALUATION. FURTHERMORE, THE LOT NUMBER WAS REPORTED TO HAVE BEEN FROM ONE OF TWO DIFFERENT ONES USED IN THE PROCEDURE; LOT # 3801151 (MANUFACTURE DATE 10/24/2014, EXPIRY DATE 09/30/2017) AND LOT # 3821671 (MANUFACTURE DATE 10/24/2014, EXPIRY DATE 09/30/2017), HOWEVER, IT CANNOT BE CONFIRMED WHICH OF THE TWO LOTS THE COMPLAINT DEVICE WAS FROM. A BATCH RECORD REVIEW HAS BEEN CONDUCTED FOR BOTH PRODUCT LOTS TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT BOTH OF THESE BATCHES OF PRODUCT WERE PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW OF THE DEPUY SYNTHES MITEK COMPLAINT SYSTEM REVEALED NO COMPLAINTS OF ANY KIND FROM EITHER OF THE TWO LOTS OF PRODUCT REPORTEDLY USED IN THIS PROCEDURE. THEREFORE, WE CANNOT DETERMINE WHAT CAUSED THE USER TO EXPERIENCE THE REPORTED EVENT; WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED FAILURE MODE. ALTHOUGH ONE POSSIBLE ROOT CAUSE COULD BE OFF AXIS INSERTION INTO THE REPORTED VERY HARD BONE OF THE PATIENT, RESULTING IN THE ANCHOR TIP BREAKING. 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.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT DURING A ROTATOR CUFF PROCEDURE THE TIP OF THEIR HEALIX ADVANCE BR 4.5MM WITH ORTHOCORD BROKE WHEN INSERTING THE ANCHOR. THE SALES REP STATED THAT THE SURGEON REMOVED THE BROKEN TIP AND THAT THE BONE QUALITY OF THE PATIENT IS VERY HARD BONE. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES BUT THERE WAS A FOUR MINUTE DELAY DUE TO THE SURGEON HAVING TO CREATE ANOTHER BONE HOLE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444937 MITEK 4.5MM HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD BIOABSORBABLE ANCHOR IMPLANT MAI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention