BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VERSALOK ANCHOR

    MDR report key: 1680274 · Received May 6, 2010

    Report

    Report Number
    MW5015844
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Date of Event
    February 19, 2010
    Report Date
    April 29, 2010
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE ARTHROSCOPICALLY INSERTING A MITEK VERSALOK ANCHOR INTO A HUMERAL HEAD, THE STAINLESS STEEL INSERTION SLEEVE (APPROX 2 INCHES IN LENGTH) WAS INSERTED INTO THE BONE. THIS PUSHER SLEEVE IS NORMALLY FIXED TO THE INSERTION SHAFT AND REMAINS A PART OF THE INSERTION MECHANISM. THIS INCIDENT WAS DISCOVERED WHEN POST-OP RADIOGRAPHS WERE TAKEN ON (B) (6) 2010, AT WHICH TIME THE SLEEVE WAS SEEN WITHIN THE HUMERAL HEAD. THERE WAS NO INDICATION OF ANY PROBLEM AT THE TIME OF SURGERY AND THE INSERTION GUN HAD SEEMINGLY OPERATED NORMALLY. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: ROTATOR CUFF REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK VERSALOK ANCHOR BONE ANCHOR MBI DEPUY MITEK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR