BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD

    MDR report key: 3910437 · Received July 2, 2014

    Report

    Report Number
    1221934-2014-00276
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K120078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMS THAT THE INSERTER TIP WELD BROKE. THIS ISSUE HAS BEEN BROUGHT TO SUPPLIER¿S ATTENTION AND BEING INVESTIGATED UNDER A MITEK NON-CONFORMANCE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITH AN UNRELATED INCIDENT WITH NO LINK TO THIS COMPLAINT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. SHOULD FURTHER INFORMATION BE PROVIDED IN FUTURE, THIS COMPLAINT WILL BE REOPENED AND EVALUATED. 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.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK; HOWEVER, IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE DISTAL TIP OF THE INSERTER ON THE CUSTOMER'S 5.5MM HEALIX ADVANCE ANCHOR BROKE WHILE ATTEMPTING TO TAKE THE INSERTER OUT AFTER SUCCESSFULLY INSERTING THE ANCHOR IN THE PATIENT'S BONE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON WAS ABLE TO REMOVE THE DISTAL TIP THAT BROKE INSIDE THE PATIENT AND WAS STILL ABLE TO USE THE ANCHOR AS IT WAS ALREADY INSERTED INTO THE BONE HOLE AT THE TIME THE INSERTER BROKE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY. THE INSERTER IS COMING BACK FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE DISTAL TIP OF THE INSERTER ON THE CUSTOMER'S 5.5MM HEALIX ADVANCE ANCHOR BROKE WHILE ATTEMPTING TO TAKE THE INSERTER OUT AFTER SUCCESSFULLY INSERTING THE ANCHOR IN THE PATIENT'S BONE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON WAS ABLE TO REMOVE THE DISTAL TIP THAT BROKE INSIDE THE PATIENT AND WAS STILL ABLE TO USE THE ANCHOR AS IT WAS ALREADY INSERTED INTO THE BONE HOLE AT THE TIME THE INSERTER BROKE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY. THE INSERTER IS COMING BACK FOR EVALUATION. NO FURTHER DETAILS WERE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387898 5.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD ANCHOR IMPLANTS MAI DEPUY MITEK NA 3742724

    Patients

    Seq Age Sex Outcome Treatment
    1