BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11CM ANGLE ATTACHMENT

    MDR report key: 3140722 · Received May 31, 2013

    Report

    Report Number
    1045834-2013-02250
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 18, 2013
    Manufacturer
    DEPUY SNYTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTOR DEVICE WAS RECEIVED FOR EVALUATION.UPON COMPLETION OF THE EVALUATION, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA REGARDING AN ATTACHMENT DEVICE IN WHICH, DURING A TYMPANOMASTOID SURGERY, IT WAS OBSERVED THAT THE DEVICE WOULD "NOT LOAD THE DRILL BIT" AND "WOULD NOT TURN". ACCORDING TO THE REPORT, THE ALLEGED DEFECT WAS OBSERVED IN THE OPERATING ROOM. A SPARE ATTACHMENT DEVICE WAS AVAILABLE. NO DELAYS IN THE SURGICAL PROCEDURE WERE OBSERVED. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242166 11CM ANGLE ATTACHMENT MOTOR, DRILL, ELECTRIC- ATTACHMENT HBC DEPUY SNYTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1