BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON REAMING ATTACHMENT F/BPLJUN 20, 2017

    MDR report key: 6696914 · Received July 10, 2017

    Report

    Report Number
    8030965-2017-13505
    Event Type
    Malfunction
    Date Received
    July 10, 2017
    Date of Event
    June 20, 2017
    Report Date
    June 20, 2017
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING LOCATION WAS UNKNOWN. THE LOT NUMBER WAS UNKNOWN. THEREFORE, DEVICE MANUFACTURE DATE IS UNKNOWN. 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 HUDSON REAMING ATTACHMENT DEVICE WAS NOT PROPERLY ATTACHING TO ANY OF THE VALID ATTACHMENT DEVICES. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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
    479435 HUDSON REAMING ATTACHMENT F/BPLJUN 20, 2017 MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY DEPUY SYNTHES POWER TOOLS N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 ATTACHMENT DEVICE