BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8CM HEAVY DUTY MEDIUM ATTACHMENT

    MDR report key: 3111883 · Received May 7, 2013

    Report

    Report Number
    1045834-2013-02090
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHMENT DEVICE WAS REC'D FOR EVAL. THE ATTACHMENT DEVICE WAS TESTED AND IT WAS OBSERVED THAT THE ATTACHMENT DEVICE FAILED THE CUTTER INSERTION AND LOCK OPERATIONS TEST. EVIDENCE INDICATED THIS WAS DUE TO USAGE WEAR OVER TIME. THE REPORTED CONDITION WAS CONFIRMED. IF ADD'L INFO IS REC'D, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT REC'D FROM THE USA STATING THAT IT WAS "HARD TO ATTACH THE DRILL AND HARD TO INSERT THE BIT" TO THE ATTACHMENT DEVICE. THE ALLEGED MALFUNCTION WAS DISCOVERED DURING SET-UP FOR A CRANIOTOMY PROCEDURE BEFORE THE PT ENTERED THE ROOM. THERE WAS A 1-2 MIN DELAY IN SURGERY. AN IDENTICAL ATTACHMENT DEVICE WAS AVAILABLE. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200003 8CM HEAVY DUTY MEDIUM ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1