BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK MILAGRO BIOCRYL RAPIDE 8X23MM INTERFERENCE SCREW

    MDR report key: 3983325 · Received August 6, 2014

    Report

    Report Number
    1221934-2014-00326
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    PMA / PMN Number
    K060830
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT BEING RETURNED AND THEREFORE NOT AVAILABLE FOR EVALUATION. IT CANNOT BE DETERMINED IF THE REPORTED FAILURE WAS CAUSED BY THE SCREW. THE PROCEDURE INFORMATION PROVIDED INDICATES THE SCREW MAY HAVE POSSIBLY MISSED THE BONE HOLE DURING INSERTION EVENTUALLY LEADING TO THIS FAILURE. OTHER THAN THIS POSSIBILITY, A ROOT CAUSE CANNOT BE DETERMINED. 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 OF ANY TYPE FOR THESE LOTS OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED IN THE FUTURE, THIS COMPLAINT WILL BE RE-EVALUATED. 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.

    Description of Event or Problem · 1

    ASSOCIATE PRESENT FOR CASE. MILAGRO WAS LATER FOUND OUTSIDE OF THE HOLE DRILLED. AFTER MRI WAS DONE ON THE PATIENT, THE IMAGE SHOWED THE MILAGRO HAD TORN THROUGH THE ROTATOR CUFF. THEY ALSO FOUND A PLASTIC PIECE OF THE CANNULA IN THE SHOULDER. ADDITIONAL INFORMATION: THE SALES REP STATED THAT DURING THE REVISION SURGERY, THE SURGEON ONLY REMOVED THE PLASTIC PIECE OF THE CANNULA. THE MILAGRO SCREW REMAINS IN THE JOINT SPACE. THE PATIENT IS CONSIDERING GOING TO A DIFFERENT SURGEON. THE SURGEON TOLD THE SALES REP THAT HE BELIEVES HE HAS MISSED THE BONE HOLE DURING THE ORIGINAL PROCEDURE NOT REALIZING IT. THE SALES REP WAS NOT ABLE TO GET THE CORRECT PRODUCT CODE AND LOT NUMBER OF THE CANNULA THAT WAS USED DUE TO THE ORIGINAL PROCEDURE BEING OVER A YEAR AGO AND A DIFFERENT SALES REP WAS EMPLOYED AT THAT POINT IN TIME, WHO IS NO LONGER WITH THE COMPANY. SEE ASSOCIATED MEDWATCH # 1221934-2014-00323.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460277 MITEK MILAGRO BIOCRYL RAPIDE 8X23MM INTERFERENCE SCREW ACL IMPLANTS HWC DEPUY MITEK NA 3671797

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention