BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGLE ATTACHMENT, SHORT 10.5CM

    MDR report key: 3811234 · Received October 11, 2013

    Report

    Report Number
    1045834-2013-05868
    Event Type
    Malfunction
    Date Received
    October 11, 2013
    Date of Event
    December 12, 2011
    Report Date
    December 21, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    ERL
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT REC'D FROM THE UNITED STATES INDICATING THAT THE DEVICE HAD "COLLAR DAMAGE WILL NOT SECURE CUTTER." IT IS KNOWN THAT THE DEVICE WAS USED IN SURGERY AND THAT THERE WAS NO INJURY. NO SURGICAL INTERVENTION WAS NEEDED, HOWEVER, IT IS NOT KNOWN IF OTHER MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524068 ANGLE ATTACHMENT, SHORT 10.5CM DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) - ATTACHMENT, PRODUCT CODE: ERL ERL DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1