BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3983141 · Received August 6, 2014

    Report

    Report Number
    1221934-2014-00323
    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
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT DEVICE WAS NOT RETURNED TO MITEK AND THEREFORE NOT AVAILABLE FOR AN EVALUATION. IT CANNOT BE DETERMINED WHAT PART OF THE CANNULA BROKE. NO FURTHER PROCEDURE DETAILS WERE PROVIDED TO DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. BASED ON THE COMPLAINT HISTORY FOR THIS FAILURE, 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.

    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 MED WATCH # 1221934-2014-00326.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460602 UNKNOWN UNKNOWN HWC DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention