BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSALOK DEPLOYMENT GUN

    MDR report key: 2041023 · Received March 28, 2011

    Report

    Report Number
    1221934-2011-00134
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 21, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC SHOULDER REPAIR, THE VERSALOK DEPLOYMENT GUN DID NOT DEPLOY 2 ANCHORS WHILE THE SURGEON WAS ATTEMPTING TO INSERT THEM INTO THE BONE HOLE FOR FIXATION. AT THIS POINT, FOR WHATEVER REASON, THE SURGEON CHOSE TO GO OPEN TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSALOK DEPLOYMENT GUN ARTHROSCOPIC INSTRUMENT HRX DEPUY MITEK 214710 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention