BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEALIX 5.5 MM ANCHOR W/ORTHOCORD

    MDR report key: 1915698 · Received December 1, 2010

    Report

    Report Number
    1221934-2010-00440
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 17, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    OUR AFFILIATE IS REPORTING TO US THAT THE PATIENT UNDERWENT A SUCCESSFUL "MINI OPEN" SHOULDER REPAIR WITH THE USE OF 3 HEALIX 5.5 MM WITH ORTHOCORD FOR FIXATION ON (B)(6) 2010. THIS REPAIR REQUIRED THE SURGEON TO GO THROUGH THE DELTOID AREA. AT THE CLOSE OF THE ANCHOR INSERTION PORTION OF THE REPAIR, THE SURGEON USED THE EXCESS ORTHOCORD SUTURE TO CLOSE UP THE DELTOID. SUBSEQUENTLY, 15 DAYS OUT, IT WAS DETECTED THAT THE WOUND WAS NOT HEALING PROPERLY, POSSIBLY A FOREIGN BODY REACTION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2010. AT THIS SURGERY, THE SURGEON NOTED THAT THERE WAS NO PROBLEM WITH THE REPAIR, ALL WAS INTACT, HOWEVER, THERE WAS EVIDENCE OF REJECTION WHERE THE ORTHOCORD SUTURE WAS EMPLOYED TO CLOSE UP THE DELTOID, THE SURGEON REMOVED THE ORTHOCORD SUTURE FROM THAT AREA AND COMPLETED THE PROCEDURE WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT... ALSO SEE ASSOCIATED MDRS 1221934-2010-00441 AND 1221934-2010-00442.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALIX 5.5 MM ANCHOR W/ORTHOCORD SOFT TISSUE FIXATION DEVICE HWC DEPUY MITEK 222232 3428982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention