BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDLOCK IMPLANT WITH INSERTER HANDLE

    MDR report key: 3193172 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00242
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STABILIZATION PROCEDURE USING THE SPEEDLOCK IMPLANT WITH INSERTER HANDLE, THE IMPLANT DID NOT RELEASE FROM THE INSERTER HANDLE, PULLING THE IMPLANT OUT OF THE BONE WHEN THE HANDLE WAS RETRACTED. DUE TO THIS EVENT, THERE WAS A 30 MINUTE SURGICAL DELAY AND THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288645 SPEEDLOCK IMPLANT WITH INSERTER HANDLE FIXATION ANCHOR, LIGAMENT, NON-BIODEGRADABLE MBI ARTHROCARE CORPORATION 1028715

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other