BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0CM SHORT ATTACHMENT

    MDR report key: 3922959 · Received July 9, 2014

    Report

    Report Number
    1045834-2014-12467
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 23, 2014
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    PK011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE BEARINGS WERE DAMAGED AND WOULD NOT LET THE BURR DEVICE PASS THROUGH THE BONE. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL WEAR OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE CUTTER DEVICE COULD NOT BE INSERTED INTO THE ATTACHMENT DEVICE. THE REPORTER CLARIFIED THAT THE EVENT OCCURRED BEFORE THE USE HAD STARTED TO BURR. AS A RESULT, THERE WAS A TEN MINUTE DELAY TO THE PLANNED SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399509 5.0CM SHORT ATTACHMENT MOTOR, DRILL, ELECTRIC - ATTACHMENT HBC DEPUY SYNTHES POWER TOOLS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUTTER DEVICE