BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK SUPER QUICK ANCHOR PLUS DUAL SUTURE

    MDR report key: 3882204 · Received June 18, 2014

    Report

    Report Number
    1221934-2014-00261
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    March 14, 2014
    Report Date
    May 23, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K052631
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND THE RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT 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. A REVIEW OF THE STERILE LOAD RESULTED IN NO OTHER SIMILAR COMPLAINTS. IT WAS REPORTED THAT NO CAUSE WAS DETERMINED FOR THE REPORTED EVENT BY THE HOSPITAL AND THAT THE PATIENT HAS RECOVERED WELL ON ANTIBIOTICS. AT THIS POINT IN TIME, 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.

    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 PATIENT HAD SWELLING AND DISCHARGE AROUND THE INCISION SITE AFTER AN OPEN ROTATOR CUFF PROCEDURE. THE SURGEON USED 1 SUPER QUICK ANCHOR PLUS ANCHOR'S IN THE PATIENT. HE DECIDED TO START THE PATIENT ON ANTIBIOTICS AND DID NOT NEED TO DO A SECOND SURGERY BECAUSE THE PATIENT RESPONDED WELL TO THE ANTIBIOTICS. THE PATIENT IS OKAY AND THE INCISION HAS HEALED SINCE.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THE PATIENT HAD SWELLING AND DISCHARGE AROUND THE INCISION SITE AFTER AN OPEN ROTATOR CUFF PROCEDURE. THE SURGEON USED 1 SUPER QUICK ANCHOR PLUS ANCHOR'S IN THE PATIENT. HE DECIDED TO START THE PATIENT ON ANTIBIOTICS AND DID NOT NEED TO DO A SECOND SURGERY BECAUSE THE PATIENT RESPONDED WELL TO THE ANTIBIOTICS. THE PATIENT IS OKAY AND THE INCISION HAS HEALED SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358370 MITEK SUPER QUICK ANCHOR PLUS DUAL SUTURE ANCHOR IMPLANTS JDR DEPUY MITEK NA 3751322

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention