BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3983917 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-12214
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "CANNOT SECURE CUTTER" WAS CONFIRMED. DURING SERVICE THE DEVICE FAILED THE PRE-REPAIR DIAGNOSTIC ASSESSMENT LOCK OPERATION TEST. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE EXPERIENCED "CUTTER WILL NOT SECURE OR TURN" DURING SURGERY. IT IS KNOWN THAT THE DEVICE WAS BEING USED DURING SURGERY; HOWEVER, NO PT OR USER INJURY OR MEDICAL INTERVENTION OCCURRED. IT IS UNK IF A DELAY IN THE SURGICAL PROCEDURE OCCURRED AS A RESULT OF THE DEVICE ISSUE. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663698 11CM ANGLE ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1