BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX BR ANCHOR W/ORTHOCORD

    MDR report key: 2000958 · Received February 18, 2011

    Report

    Report Number
    1221934-2011-00056
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    October 29, 2010
    Report Date
    February 14, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A SUCCESSFUL SHOULDER REPAIR ON (B)(6) 2010 WITH THE USE OF 4 HELIX ANCHORS FOR FIXATION. AT THIS PROCEDURE, THERE WAS A REPORTABLE ISSUE OVER AN EXPRESSEW NEEDLE; TIP BREAKAGE, UN-RETRIEVED DEVICE FRAGMENT; SEE MDR 1221934-2010-00247. HOWEVER, THE PATIENT PRESENTED AT SOME POINT POST-OPERATIVELY WITH "OOZING" FLUID AT THE WOUND SITE. ON (B)(6) 2010, THE PATIENT RETURNED TO THE SURGERY CENTER FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE, AT WHICH TIME THE SURGEON ALSO REMOVED THE ORIGINAL 4 HELIX FIXATION DEVICES. THERE IS INDICATION HERE THAT THERE WAS NO RE-FIXATION AT THIS PROCEDURE, JUST DEVICE REMOVAL. THE PATIENT WAS SCHEDULED AND RETURNED TO THE CENTER ON (B)(6) 2010, FOR SHOULDER REPAIR. THIS IS ALL THAT IS KNOWN AT THIS TIME; HOWEVER, THERE ARE QUESTIONS OUT FOR FURTHER DETAIL AND CLARITY. ALSO SEE ASSOCIATED MDRS 1221934-2011-00057, 1221934-2011-00058 AND 1221934-2011-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALIX BR ANCHOR W/ORTHOCORD SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 222233 3374566

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention